EDUCATION LAW

Cannabis Laws and Research at Colorado Institutions of Higher Education by Frank Robison and Elvira Strehle-Henson

Almost 3,000 years ago Hippocrates purportedly stated, "There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance." Cannabis's polemic presence in society is incontrovertible­ simultaneously, it has therapeutic and medical merits, is less harmful than tobacco and alcohol, is harmfol and addictive and a gateway drug, and is an industrialpanacea. This article discusses how thefoderallegal scheme to regulate controlled substances has affected scientific research with and on cannabis.

he "green rush" has been on since 1996, when California There is a resulting void in fact-based scientific data and informa­ decriminalized marijuana for medical purposes. Today, 23 tion about the cannabis plant and what it and its constituent com­ T states and the District of Columbia, Guam, and Puerto pounds actually do to the human body. Whether cannabis is less or Rico have passed or enacted laws that allow Cannabis sativa L more hannful or beneficial than other controlled substances or legal (cannabis)1 to be used for medical purposes, giving new meaning to substances, such as alcohol and tobacco, is one of many scientific Justice Brandeis's dissent that a "courageous State may, ifits citizens questions about cannabis to which collectively few answers exist. choose, serve as a laboratory; and try novel social and economic According to a 2013 Gallup poll, almost 60% of U.S. citizens experiments without risk to the rest of the country."2 think marijuana should be legal. 6 Approximately 20 million people Several states have legalized and regulated the cultivation, sale, in the United States age 12 and over (about 7.5% of the people sur­ distribution, or possession of cannabis for medical and recreational veyed) are current users of marijuana-that is, they use marijuana purposes, but these activities continue to be violations of various at least once in any given month. federal laws and may be prosecuted by federal authorities.3 In spite Last year, President Obarna remarked, "I smoked pot as a kid, of the federal specter of continued prosecution, over the past six and I view it as a bad habit and a vice, not very different from the years, the federal government has overtly adjusted its enforcement cigarettes that I smoked as a young person up through a big chunk priorities in states that have legalized or decriminalized marijuana, of my adult life. I don't think it is more dangerous than alcohol. "1 essentially fueling the green rush.4 Others, including many parents of sick children who have moved During this time, the federal government has not altered or to Colorado since the state legalized medical marijuana, might dis­ addressed the corresponding regulatory paradigm for conducting agree with the President's characterization of marijuana as a vice. research. As a result, at the state level, the cannabis money tree is in They use it as an alternative or supplement to FDA-approved med­ full bloom, but research at federally funded institutions remains icines to treat serious illnesses, such as Dravet and Lennox·Gastaut stunted. syndromes, which are severe forms ofepilepsy. Hemp, industrial hemp, recreational marijuana, and medical mar­ Insufficient data exists to establish how marijuana is affecting ijuana are a variety of strains of cannabis (cannabis nomenclature people who consume it. The Colorado Department of Public and its respective use in this article are addressed in note one). Health and Environment (CDPHE) states that it has been unable Except for the cultivation and research ofindustrial hemp by insti­ to establish empirically appropriate dosing of medical marijuana.8 tutions of higher education and state departments ofagriculture in In part, because of the lack of data, a significant interest and states that allow hemp production, federal law treats cannabis demand for low trans-a9-tetrahydrocannabinol (THC)/high equally. The Controlled Substance Act (CSA) broadly prohibits and cannabidiol (CBD) cannabis strains exists. THC has psychoactive criminalizes the cultivation, possession, importation, and distribu­ properties, while CBD does not. tion of marijuana, providing for a limited exception for federally This interest is illustrated by the thousands of parents seeking approved research.s cannabis products to treat children with chronic or life-threatening

About the Authors Frank Robison serves as Assistant University Counsel in the University of Colorado Boulder's Office of University Counsel-(303) 492-7461, [email protected]. Elvira Strehle-Henson serves as Managing Senior Associate University Counsel in the University of Colorado Boulde~s Office of Uni­ versity Counsel-(303) 492-7481, [email protected]. This article is not connected to the authors' duties at the University of Colorado and does not represent the legal opinion or views of the Univer­ sity. The authors thank the following people for their valuable time and input: Rick Doblin, Moni Flesh­ ner, Ken Gershman, Kent Hutchison, Nolan Kane, lia Luber, Duane Sinning, and Daniel Vergara.

The Colorado Lawyer I October 2015 1 Vol. 44, No. 10 73 CANNABIS LAWS AND RESEARCH AT COLORADO INSTITUTIONS OF HIGHER EDUCATION illnesses ranging from seizure disorders to cancer. Organizations While the CSA recognizes that many controlled substances such as Realm of Caring Foundation Inc. and Stanley Brothers "have a useful and legitimate medical purpose and are necessary to Social Enterprises LLC provide cannabis-based medical services maintain the health and general welfare of the American people,"'4 or products that-some assert-have successfully treated such ill­ it is also "a dosed regulatory scheme."1S The federal government nesses.9 Furthennore, although federal agencies recognize the need classifies marijuana in the most restrictive of five controlled sub• to facilitate research-the Food and Drug Administration (FDA) stance categories.16 It is in same category as heroin, ecstasy, and and National Institute ofDrug Abuse (NIDA) acknowledge that LSD because of the determination that marijuana has a high cannabis may contain compounds that are viable for treating potential for abuse and no accepted medical utility, and that there is epilepsy, nervous system disorders, and other illnesses-the federal a lack of accep[ed safety standards for marijuana use under med· legal scheme continues to stymie research.1° ical supervision.17 Notably, opium, cocaine, and methamphetamine Congress has attempted to modifY the current paradigm on a fall into a less restrictive category than marijuana. 18 number of occasions.tt Most recently, on May 13, 2015, U.S. sena­ Under federal law, cultivation, sales, distribution, use, or posses• tors Cory Gardner and Michael Bennett and several other sena­ sion of marijuana for research purposes requires registration with tors introduced Senate Bill (S) 1333, the Therapeutic Hemp Med­ the Drug Enforcement Agency (DEA), the primary federal agency ical Access Act. This Act would amend the CSA to exclude CBD charged with enforcing the CSA 19 and other lowTHC/high CBD strains ofcannabis from the CSAS As a party to the Single Convention on Narcotic Drugs, the definition of marijuana. This exemption would encompass strains United States is required to create "a government agency," which is that contain less than .3% ofTHC but contain high concentra­ NIDA, to control the distribution and growth of marijuana.20 tions of CBD that, at least based on observational data between Although the Single Convention does not limit the number of physicians and patients, may be medically beneficial. While regula­ sources for which marijuana can be grown, since 1968, NIDA has tory hurdles would still exist, such as an FDA Investigational New awarded the sole contract to the UniversityofMississippi. To date, Drug (IN D) application, exempting CBD and low THC/high attempts to obtain approval for more than one approved source for CBD strains from being classified as Schedule I drugs under the marijuana have been unfruitful and deemed unnecessary by the CSA would facilitate the clinical trials (trials in which a researcheer DEA.lt administers marijuana to human subjects) necessary to approve or In addition, NIDA mandates procurement of research mari­ disprove the anecdotal evidence. juana from the University of Mississippi, which has limited vari­ This article discusses the existing legal landscape for marijuana eties and quantities.22 research and the concomitant lack of federal guidance and action Across the United States, approximately 1.5 million residents despite the growing number of states that have legalized marijuana have received recommendations from medical doctors to use mar­ for medical or recreational purposes. It also explains the conflict­ ijuana as part of a treatment plan.23 In Colorado, medical mari· ing state and federal regulatory frameworks that presently exist and juana has been legal for over fifteen years. In January 2014, Colo­ the resulting vacuum in U.S. research. rado became the first state in the nation to regulate the cultivation, distribution, and sale of recreational marijuana. This was followed Cannabis Research: closely by Washington and later by Alaska, Oregon) Rhode Island, Historical Roots to Current Landscape and Washington DC.l 4 Based on current registrations with the CDPHE, Colorado has In spite of recognized industrial and medical uses for cannabis, approximately 115,000 medical marijuana patients, of whom at the turn of the 20th century anti-marijuana sentiments took almost 500 are minors.25 In Colorado, adult medical users require a 12 hold in the United States. Cannabis entered a period where soci­ recommendation from a doctor certifYing that the patient "'might ety rejected its recreational, medical, and industrial uses and benefit from the medical use of marijuana" because of any of the research stagnated. Later, the United States became a party to sev­ following conditions: HIVI AIDS, glaucoma, severe pain, cachexia, eral international treaties restricting marijuana use, and Congress severe nausea, seizures, or persistent muscle spasms.26 Minors 13 ultimately passed the CSA in 1970. require two physician certifications from separate doctors and parental approval for medical purposes. 27 A person at least 21 years old is now able to purchase marijuana for personal, recreational consumption.lll Scientists in Colorado's federally funded universi­ ties are barred from purchasing the same marijuana from the same retail dispensaries for their research purposes. Research on widely available cannabis strains is warranted because while the use ofthese strains is widespread, there has been minimal research on their effects. Moreover, as discussed below, Brendan L. Loy research on these strains also has value because many physicians Appellate Specialist assert that they have medical benefits. Consequendy, a public inter­ l A BllH WOOD, RIS ~....~ est exists in creating an evidence-based understanding of the V V.N & HAMESr.c. effects-both positive and negative--of cannabis on adults, ado­ lescents, and children. Selected by Super La"')'crs to tbc 2015 Colorado Rising Stars list This year, the CDPHE has awarded S9 million in grants to research the medical properties of marijuana and its derivatives. However, due to the federal regulatory scheme, these state funds

74 The Colorado Lawyer I October 2015 I VoL 44, No. 10 I CANNABIS LAWS AND RESEARCH AT COLORADO INSTITUTIONS OF HIGHER EDUCATION

are unlikely to be used to conduct research on the issues that matter marijuana could also be deemed proceeds of an illegal transac­ to Colorado-the effect ofColorado marijuana on Coloradans and tion.39 Additional statutory violations include aiding and abetting its visitors. of or conspiracy with respect to applicable laws such as money laundering statutes or the CSA. 40 Indeed, the 2014 DOJ financial Legal Parameters of Cannabis Research crimes memorandum emphasizes that the federal money launder­ ing statutes are applicable to marijuana-related transactions in the Over the past several years, the federal government has adjusted 4 its enforcement priorities regarding states that have legalized or states where marijuana purchases are otherwise lega1. 1 decriminalized marijuana, but it has not significantly addressed the Furthermore, both the Colorado and the U.S. Supreme Courts regulatory research paradigm. Specifically, in 2009, the Department have hdd that federal law applies to conduct that has a nexus to marijuana. On two occasions, the U.S. Supreme Court hdd that ofJustice (DOJ) issued a memorandum stating that medical mari­ 4 juana operations in medical marijuana states are not a prosecutorial the CSA preempts state-based medical marijuana laws. 2 In June priority, arguably prompting the first major expansion of mari­ 2015, in Coals v. Dish Network, the Colorado Supreme Court juana-inspired entrepreneurial activities.29 The DOJ responded to found that, for purposes of the Colorado lawful activities statute, this expansion by releasing another memorandum in 2012, estab­ CRS § 24-34-402.5, the term "lawful" applies to activities that are lishing that large-scale commercial grow operations are an enforce· lawful under both state and federallaw."J The Court reasoned that ment priority, even if the marijuana is purportedly for state medical because the CSA has classified marijuana as a Schedule I drug, th; marijuana users.30 use, possession, and manufacture of marijuana, with the exception In June 2013, the DOJ updated its guidance in a third memo­ of federally approved research, is a federal crime. Citing Gonzales randum (Cole Memo creating the current federal enforcement v. Raich, the Court stated, "if there is any conflict between federal D), 44 priorities connected to marijuana, and simultaneously affirming and state law, federal law shall prevail." Indeed, even the State of that no state law "provides a legal defense to a violation offederal Colorado does not "disputeD the priority ofthe CSA compared to law, including any civil or criminal provision of the [CSA]."31 In state laws legalizing marijuana-in this sense, the CSA is 4 2014, noting that the panoply of risks associated with marijuana supreme. " S In spite of the DOJ's trend to relax enforcement includes robbery, unreported income, and questionable accounting efforts, taking the certifications and the jurisprudence together, practices, the DOJ and the Department of the Treasury issued sep­ federally funded institutions of higher education appropriately arate memoranda that reiterated the Cole Memo II, and advised approach cannabis research carefully. that marijuana•related conduct could implicate financial crimes.l2 Notwithstanding the above proscriptions, federal law provides In 2013, the DEA published an update to its position on mari­ three general pathways to conduct research with cannabis. First, juana, but only with respect to smoked marijuana, reciting the despite the CSA's prohibition and criminalization of the growing, attributes of a Schedule I substance.U An array ofissues salient to processing, and use of marijuana, there is a limited exception for research involving cannabis other than smoked marijuana, ranging the Department of Health and Human Services (HHS), the from alternative methods of consumption like vaporizers, edibles, National Institutes of Health (NIH), the DEA and-if involving and transdermal patches, to successes in treating Dravet's syn­ human subjects-FDA-approved research. In 2013, the DEA drome in children using CBD, are not addressed in the DE.Ns acknowledged that 125 researchers were registered to study mari­ position paper.34 juana, 18 of whom were approved to conduct research with smoked marijuana. 46 In June 2015, the DEA reported a jump in Seve~ fe~eral statutes regulate controlled substances on college and umverstty campuses. These statutes are critical to research active registered users to 265, emphasizing 41 of those are regis- institutions because they require institutions that receive federal funding in the form of grants and financial aid dollars to certify compliance with applicable federal laws. The Drug Free Workplace Act of 1988 requires federal contractors and grantees to provide drug-free workplaces as a precondition to receiving a contract or grant from a federal agency such as the National Science Founda­ tion or the National Institutes ofHealth.35 Likewise, the Anti­ OHOPE Drug Abuse Act of 1988 requires institutions to certifY to the Sec­ MEDIATION retary ofEducation that they will provide a drug-free workplace as a precondition for receiving federal funds.l6 Similarly, the Drug Free Schools and Communities Act, also known as the Drug Free 35 years of combined experience Schools and Campuses Act, mandates that, as a condition of receiving federal financial assistance, a college or university must certifY that "it has adopted and implemented a program to prevent Litigation ·'Ifansactions ·Mediation the unlawful possession, use, or distribution of illicit drugs or alco­ hol by students and employees."37 An ~nstitution or person may also be subject to liability by Serving Parries & Counsel in the Fronr-Range & ~Slope: acceptmg money from the cannabis industry-whether in the form ofsponsored research, grants, or gifts-for scientific research. (JOJ) 906)709 II Hope-Mediation.com Specifically, federal anti-money laundering statutes make it illegal KENNETII R. HOPE AITORNEY ·MEDIATOR to receive monies from transactions that are prohibited under fed­ erallaw. 38 Moreover, revenues from the sale and manufacture of

The Colorado Lawyer 1 October 2015 1 Vol. 44, No. 10 75 CANNABIS LAWS AND RESEARCH AT COLORADO INSTITUTIONS OF HIGHER EDUCATION tered to research extracts such as CBD. As ofJanuary 31,2014, While the Farm Bill defines an agriculture pilot program, it does NIDA funded 28 active grants related to applied scientific research not define academic research. The U.S. Department ofAgriculture with marijuana using human subjects or animals. 47 By contrast, the (USDA) and other federal agencies decline to define academic study of pharmaceutical opioids, Schedule II and III substances, is research, leaving hemp state stakeholders to interpret its mean­ commonplace. 48 In spite of the relative paucity in cannabis ing.s s J#bsters defines "academic" to mean "of, relating to, or asso­ research, NIDA states that it "has provided and continues to pro­ ciated with an academy or school especially of higher learning."S9 vide funding for research related to therapeutic uses ofcannabi ­ Considering that research at institutions ofhigher education covers noids."49 Consistent with the lack of research, the FDA has not a wide spectrum, ranging from basic bench research to applied sci­ approved any drug product containing or derived from botanical entific research with human subjects or animals, Congress appears marijuana.5{1 to permit a broad range of research, so long as the institution com­ To use marijuana in applied scientific research with human sub­ plies with other applicable laws, such as submitting an lND appli­ jects, a researcher must obtain:51 iffunded by NIH (1) approval of cation to the FDA60 the research protocol by the NIH; (2) FDA IND application In spite of the lack ofguidance from federal agencies, Congress approval; and (3) a DEA Schedule I registration. 51 If not funded established its hemp priorities in the 2015 Appropriations Bill, by the NIH, (1) FDA IND approval; and (2) a DEA Schedule I which provides that the DOJ and the DEA may not use federal registration.5 3 funds to hinder hemp research conducted under the Farm Bill.61 For animal studies, a researcher must obtain: (1) Institutional Taking a comprehensive interpretation ofacademic research along Animal Care and Use Committee (IACUC) approval; (2) NIH or with Congress' decision to defund expressly DOJ and DEA activi­ HHS protocol approval; and (3) DEA Schedule I registration.54 ties with respect to hemp research, federally funded institutions Basic research requires (1) NIH or HHS protocol approval and (2) appear to have a mechanism to conduct a broad range of research a DEA Schedule I Registration.ss using hemp. With limited exceptions (Schedule I license holder to Schedule Finally, federal regulations exclude the stalks and sterile seeds I license holder material transfers and limited DEA-approved from the CSA's definition ofmarijuan a. 62 Accordingly. research on international sources), the cannabis must be obtained from NIDA's stalks and sterile seeds as well as materials and products derived sole source, the University of Mississippi. While the DEA is most from stalks, fiber, and sterile seeds, including some CBD products, frequently the entry point for a researcher seeking federal approval, paper, rope, clothing, animal feed mixtures, soaps, shampoos, car other agencies, FDA and NIDA, may receive and review protocols parts, biofuels, and many others, is permissible.(>). directly to obtain certain approvals ultimately required to obtain a Institutions of higher learning have broad latitude to cultivate DEA registration. 56 and research hemp, including its constituent compounds, under the Congress passed the Agricultural Act of 2014 (Farm Bill), Farm Bill. Because of increasing popularity and practical which includes a provision to allow departments ofagriculture and omnipresence of CBD, CBD merits general consideration. CBD's higher education institutions in states that have legalized hemp to, regal status remains uncertain. A challenge for hemp product man· notwithstanding any federal law, including the CSA, "grow or cul­ ufactures, particularly CBD product manufactures, is legally tivate industrial hemp ifindustrial hemp is grown or cultivated for obtaining materials derived from the stalks and sterile seeds, given purposes of research conducted under an agricultural pilot program that cultivation and possession of the cannabis plant generally or other agricultural or academic research. "57 remains illegal under federal law. Certain producers ofhemp•based (including CBD-based) products claim their CBD is derived from the stalks and sterile seeds of hemp plants grown overseas, which would arguably make the CBD exempt from the application of the CSA ROBERT H. RUSSELL, II Even if commercially available CBD is legal, barriers to using Now providing family law services at: this CBD for research exist. The FDA has not recognized CBD as Generally Regarded as Safe (GRAS) for human consumption.64 Likewise, the DEA's final rule on legal hemp materials and prod­ ucts specifically excludes materials used for human consumption.jjS Littleton Alternative Indeed, the DEA's position on CBD is clear- it is a Schedule I substance. Further, the FDA concluded that CBD "products are Dispute Resolut1on INC. excluded from the dietary supplement definition under Section 190 I W. Uulcton Boulevard 201(ff)(3)(B)(ii) of the Federal Food, Drug and Cosmetic Act," Liulc10n, Colomlo 80120 reinforcing that human subject research with CBD requires an 303-798-2533 66 303-798·2526 (f:u:} IND. russc:ll @l~drmcdi~!ion. cont The legal status ofCBD is curious on many levels. Not only are • Arbitration Colorado-made CBD products generally derived from the flow­ • Muliatioll ers (buds are rich in resin) of the cannabis plant but also the CSA's • Grsr Comult!.lritJn definition ofcanna bis captures CBD, even if the CBD is derived •PODM from the stalks and sterile seeds (the CSA's definition of marijuana • &ttlrmmt Con/Nrllrn deliberately includes all cannabis resins). In many respects, the • Expm \Vimnr • Appoillttd judgt' adage "everyone is doing it, so it must be legal" appears to have taken hold with respect to CBD, but that still does not make CBD

76 The Colorado Lawyer 1 October 2015 1 Vol. 44, No. 10 CANNABIS LAWS AND RESEARCH AT COLORADO INSTITUTIONS OF HIGHER EDUCATION research legally compliant. In spite of the general legal uncertainties stance because marijuana has demonstrated to have a wide range of CBD, Colorado institutions of higher learning may conduct of useful medical properties. 73 At another extreme, researchers academic and agriculture research on and with hemp, including its claim that marijuana is dangerously addictive.74 One group, based constituents compounds, under the Farm Bill. on a NIDA- funded study, claims that chronic marijuana use causes In addition to the pathways explicitly provided for by law, feder­ the frontal cortex ofthe brain to shrink.7 S ally funded institutions may conduct a broad range ofob servational ProCon.org outlines peer-reviewed studies conducted from studies- that is, collecting data on persons who self-acquire and 1990 to 2014 using the marijuana plant, extracts, and pharmaceu­ self-administer marijuana-requiring approval from their institu­ tically produced derivatives, such as Sativex and Epidiolex.76 The tional review boards (a group designated to review and monitor majority ofthe se studies-that is, 68%-conclude that marijuana human subjects research). Observational studies, however, do not has positive health benefits in relation to the medical condition always provide reliable data because it can be difficult to maintain studied.77 Only 10% of the studies conclude that marijuana is not robust ~cientific controls throughout these studies. For example, an useful to treat the condition studied or actually exacerbates the observational study of regular recreational users may pose reliability condition or otherwise has negative effects.78 The remaining 22% problems because researchers cannot ensure that the study partici­ ofs tudies produced inconclusive results. 79 Regardless of the points pants are self-administering marijuana as communicated to and by of view, without clinical trials, gaps in cannabis research will con­ the researcher. tinue to exist.so Ofcourse, observational studies may lead to clinical studies (tri ­ Approximately 500 compounds have been identified in als in which a researcher administers marijuana to human subjects). cannabis.•• Among these compounds, approximately 80 to 110 are However, under the federal scheme, a researcher is required to use cannabinoids,Sl which are chemicals unique to the cannabis different, federally approved cannabis strains procured from select plant.•) THC is merely one cannabinoid. Cannabinoids exert their federally approved s-ources.67This makes it difficult, if not legally effects by interacting with cannabinoid receptors present on the impossible, for Colorado researchers to administer studies on surface of cells in many parts of the body, primarily the central human subjects using the same cannabis strains in ob5ervational nervous and peripheral and immune systems.84 While THC and and clinical studies. CBD are the most commonly known constituents of cannabis, approximately 80 to 110 other cannabinoids have not been Research researched. 85 Federal law restricts research on a substance that Colorado reg• The effects ofTHC and other cannabinoids may be moderated ulates in a manner similar to alcohol.611 Dissatisfaction with the or influenced by the other components of the plant, most particu­ federal marijuana research scheme is decades old.69 Marijuana's larly other cannabinoids and terpenoids (the chemical compounds 86 classification as a Schedule I controlled substance limits cannabis responsible for cannabis's odor). Certain compounds may co-vary research {and, it follows, cannabis-based drug development) with other compounds to produce positive or negative medicinal 81 because of the CSA's articulated presumption that cannabis has no effects. Cannabinoids and compounds may vary from plant to accepted medical utility, a high potential for abuse, and a lack of plant, strain to strain, and harvest to harvest. These variances, as a accepted safety standards. result, may produce a wide range of research results. In addition, maintaining a single source of cultivated research While NIDA might argue that the University of Mississippi marijuana at the University of Mississippi is an obstacle to under­ uses standardized growing conditions, no Current Good Manu­ standing whether strains not cultivated by the federal government facturing Processes (cGMPs) for cannabis or its constituent com- and their respective constituent compounds have scientific merit. The competing interests of science, politics, and societal norms affect the cannabis debate. Yet, to have an informed debate, researchers at federally funded institutions argue that they need to study the plant that people are actually consuming, and many would also like to control the respective production of cannabis. Consequently, Colorado is fuced with a conundrum. The federal government's hands-off attitude to enforcement of federal law appears to correlate directly with the massive growth in the mari­ juana industry. Entrepreneurs have seized the opportunity to invest directly in marijuana businesses as well as in ancillary businesses Disability Professionals like grow equipment, enterprise software, and child resistant con­ tainers.70 Indeed, the financial incentives are well documented. 71 offering statewide service However, this economic growth has not translated to the same Western Professional Associates, Inc. degree of growth in research on the plant and plant derivatives. A Focusing on personal gains and state revenues, while ignoring the non-profit law finn potential negative and positive effects of the cannabis Coloradans Referral fees available actually consume, leaves a gap that Colorado institutions of higher Palrlck H. Donahue education could fill but legally are constrained from filling. General Counsel Organizations and researchers have reached vastly different con­ (866) 825-7489 clusions regarding the effects of marijuanaP At one extreme, some www.disabilltyprofessionals.org researchers protest its current classification as a Schedule I sub-

The CCI/orado Lawyer 1 October 2015 I Vol. 44, No. 10 77 CANNABIS LAWS AND RESEARCH AT COLORADO INSTITUTIONS OF HIGHER EDUCATION pounds exist in the United States, which the FDA requires for the matic stress disorder (PTSD) in 76 U.S. veterans; however, in spite sale offood, drug products, and active pharmaceutical products. a ofa five~year attempt, it has not yet received a Schedule I license. 99 Critics ofthe University of Mississippi laboratory maintain that The Colorado General Assembly also directs the Colorado the product is poor quality and is not readily available to Attorney General to seek permission from NIDA to allow Colo­ researchers, its cannabinoid content greatly varies, and its THC rado universities to grow marijuana for research purposes.100 potency is significantly lower than what is on the retail market.~ Accordingly, emphasizing the lack of data, the Attorney General Indeed, in 2014, the director of the laboratory stated, "Maybe if stated, "Current research is riddled with bias or insufficiencies and [marijuana] becomes legalized, we could start producing high­ often conflict with one another{.] [l]t is critical that we be allowed quality materials for a pharmaceutical product. "90 to fill the void ofscientific research, and this may only be done with Research with synthetic THC (dronabinol, Marino!) and a syn­ your assistance and cooperation. "101As ofjuly, the federal govern­ thetic analog ofTHC (nabilone, Cesarnet) is limited because it ment had yet to respond. does not have the number of variables that are typically in flux in Jn addition to the research grants, the Colorado General cannabis plants. In addition to the variances from crop to crop, Assembly mandated that CDPHE study the impact of marijuana cannabis compounds may produce different effects depending on on public health, creating the Retail Marijuana Public Health the method ofconsumption, such as combustion, vaporization, eat­ Advisory Committee (RMPHAC).l02 This committee identified ing, or transdermal applications. Scientific and medical questions "important research gaps related to the population-based health appear infinite. effects of marijuana use," recommending that Colorado support The State ofColorado is taking an active but limited role with research to fill the health knowledge gaps, but this committee's respect to filling the research gap. Colorado law requires marijuana mandate is limited to general research about the effects of mari­ businesses to conduct only minimal testing on cannabis and juana on targeted social and economic groups.103 In spite ofbeing cannabis products.91 Regulations provide that licensed testing fucil­ outside of the RMPHAC's mandate, the committee highlights ities may conduct research, but do not expand on what constitutes that more research is needed on the potential therapeutic benefits research,92 and the state's actual practice is limited to specific, basic of marijuana. tests at certified and licensed laboratories. 93 Further, in addition to testing for contaminants, marijuana businesses are currently only Conclusion required to measure and label THC levels, ignoring the quantities Almost 50 years ago, the federal government, through the CSA, ofother cannabinoids.94 criminalized the cultivation, distribution, and possession of can­ With respect to medical marijuana, the Colorado legislature nabis, with an exception permitting research on a highly controlled authorized use of the Medical Marijuana Registry's excess cash basis. Since the passage of the CSA, perceptions on cannabis have funds to research health benefits and side effects of marijuana, del­ changed, but the corresponding federal legal framework remains egating authority to administer research grants to the CDPHE.95 largely unchanged. Even though the FDA, NIDA, and the NIH The CDPHE established the Medical Marijuana Research Grant acknowledge that cannabis may contain compounds that are viable Program to fund medical marijuana studies.~6 Ofthe nine research for treating epilepsy, nervous system disorders, and myriad other grants 5elected for funding and to be awarded by the CDPHE, six illnesses, they have not taken action to facilitate research on mari­ are observational and three are randomized, double-blind, placebo­ juana strains that are widely available on the retail market, much controlled studies involving human subjects.97 The double-blind less Colorado strains.104 studies contemplate using marijuana obtained from the University ofMississippi. not Colorado strains. Today, several months after the award, none of the iovestigators Notes 98 has a Schedule I license from the DEA. The Multidisciplinary 1. In this article, "marijuana" refers to any Cannabis sativa L. plant that Association for Psychedelic Studies (MAPS), an awardee, intends has a THC concentration ofmore than 0.3% on a dry weight basis. Under to study the use of marijuana for treating symptoms of posttrau- the CSA, marijuana "means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof, the resin extra.cttd from any part ofsuch plant; and every compound, manu&awe, s:Ut, derivatiVI:, mix­ ture, or preparation of such plant, its seeds or resin." 21 USC § 802(16). This article refers to "hemp" as any Cannabis sativa L. plant that has a THC conccnttation ofnot more than 0.396 on a dry weight basis. Under§ Jones Legal Nurse Consulting 7606 of the Farm Bill, ..industrial hemp' means the plant Cannabis sativa L . and any part of such plant. whether growing or not, with a delta•9 Rebecca Jones, MSN, CNM, CLNC tettahydroc:mnabinol (fHC) concentration of not more than 0.3 percent [email protected] on a dry weight basis." 7 USC § 5940. In this article, wcannabis" means all Cannabis sativa £.,including marijuana and hemp. 2. New State let Co. v. Liebmann, 285 U.S. 262,311 (1932) (Brandeis, case Screening J., dissenting). Medical Records Review 3. HHS, MNational Survey on Drug Use and Health: Summary of National Fmdings" 17 (2013); 21 USC§§ 841(b) (penalties and punish­ Medical Research ment for the manufacture, distribution, or posiession of cannabis range Locate Testifying Experts from five years to life in prison or $250,0000 to S50,000,000 fines or both), 860 (increasing penalties and fines for violations within 1,000 feet of 1-575-578-9915 a school, college, or university), 856{a)(1) and (2) (making it unlawful to knowingly open, lease, rent, use, or maintain any place, whether penna-

78 The Colorado Lawyer I October 2015 I Vol. 44, No. 10 CANNABIS LAWS AND RESEARCH AT COLORADO INSTITUTIONS OF HIGHER EDUCATION nendy or temporarily, for the purpose of manufacturing, distributing, or (1934) adopted by 47 states and Washington DC; the Marijuana Tax Act using any controlled substance). Set also DO], "Guidance on Marijuana of1937, Pub. L. No. 75-238 50 Stat. 551 (1937) invalidated by uary v. Enforcement" (June 29, 2011) (Cole Memo 1), www.justice.gov/sites/ Unittd Stat~s, 395 U.S. 6, 28-29 ( 1969}; Editorial, "The Federal Marijuana default/files/oip/legacy/2014/07/23/dag·guidancc:-2011-for-medical­ Ban is Rooted in Myth and Xenophobia," Tht: Ntw York Timt:s (July 29, marijuana-use.pdf, DOJ, uGuidance on Marijuana Enforcement" (Aug, 2014}. 29, 2013) (Cole Memo 11), www.justice.gov/iso/opalresources/30520138 13. See The Single Convention on Narcotic Drugs ofl961, as amended 29132756857467.pdf; DOJ, "Guidance Regarding Marijuana Related by the 1972 Protocol (restricting legal marijuana uses to medical and sci­ Financial Crimes" (Feb. 14, 2014) (DOJ Financial Guidance), www.jus entific purposes, and requiring international cooperation and enforce­ tice.gov/sitcsldefault/files /usao-wdwa/legacy/2014/02/14/DAG%20 ment). Memo%20-%20Guidancc%20Regarding%20Marijuana%20Related%20 14.21 usc§ 801(1). Financiai%20Crimes%202%2014%2014%20%282%29 .pdf, U.S. Depart­ 15. Gonzalt:s v. Rtzich, 545 U.S. 1, 13 (2005) (citing 21 USC §§ 841(a) ment of the Treasury, "Financial Crimes Enforcement Network, Bsa (1) and 844(a) ("Congress devised a closed regulatory scheme making it Expectations Regarding Marijuana-Related Businesses," FIN-2014-G001 unlawful to manufacture, distribute, dispense, or possess any controlled (Feb 14, 2014) (FinCEN Guidance), www.fincen.gov/statutes_regslguid substance except in a manner authorized by the CSA. ")). ance/pdf/FIN-2014-GOOl.pdf. 16.21 USC§ 812(c) Schedule l(b)(10). 4. Cole Memo I, supra note 3; Cole Memo 11, supra note 3. 17.21 USC§ 812(bX1) and (c)(lO}. 5. 21 usc § 801(2). 18.21 USC § 812{c) Schedule II(a). 6. Swift, "For First Time, Americans Favor Legalizing Marijuana 19.21 usc§ 841. Support Surged 10 Percentage Points in Past Year, to 58%," Gallup (2013). 20. The Single Convention on Narcotic Drugs of 196l,art. 28. 7. Remnick, "Going the Distance On and Off the Road with Barnck 21. 74 Fed. Reg., 92101 (Jan. 14, 2009}; Craker v. Drug Enforcemmf Obama," Tht:Ntw Yorker(Jan.27,2014). Admin., 714 F.3d 17,22 (1st Cir.2013). 8. Email from Ken Gershman, CDPHE Medical Marijuana Grant 22. As a party to the Single Convention on Narcotic Drugs, an interna­ Manager (June 8, 2015) (on file with authors). tional narcotics control treaty, the United States must establish a national 9. &~. t:.g., Healy, "Families See Colorado as New Frontier on Med· agency to control the cultivation and distribution of marijuana. Single ical Marijuana," T~ Ntw York Times (Dec. 5,2013). Su also Gonzalez, "For Convention on Narcotic Drugs, 1961, Articles 4, 23, and 28. In the United Children's Seizures, Turning to Medical Marijuana," T~ Ntw York Times States, NIDA is the agency vested with such authority. NIDA is a sub­ (March 26,2015). agency of the NIH, which in tum is a component of the HHS. Since 10. Mixed Signals: The Administration's Policy on Marijuana-Part 1968, NIDA has contracted with the University of Mississippi's National Four-the Health Effects and Science Before the Subcommittee on Gov­ Center for Natural Products Research to grow, harvest, and process mari­ ernment Operations of the House Committee on Oversight and Govern­ juana as well as to sell it to licensed facilities across the country for research ment Reform, 113th Cong. (2014) (statement of Douglas C. Throckmor­ purposes (hereinafter NIDA Federal Approved Source). ton, MD, Deputy Director for Regulatory Programs, Center for Drug 23. Belville, "America's One Million Legalized Marijuana Users, Evaluation and Research, FDA, HHS) (granting GW Pharmaceuticals National Organization for the Reform of Marijuana Laws" (May 31, Fast-Track designation to its investigational drug product to (1} Sativex, 2011}, blog.norml.org/2011/05/31/americas-one-million·legalized·mar­ composed primarily of two cannabinoids: CBD and THC, for treatment ijuana·uscrs; Medical Marijuana, Pros and CoM. No. of Legal Medical of pain in cancer patients; and (2) Epidiolex to treat Dravet syndrome}. See Marijuana Patients, ProCon.org (Oct. 27,2014) (indicating that as ofOct. also NIDA and American Epilepsy Society (AES) Town Hall Forum: 2014 there are 1,137,069legal medical marijuana users in medical mari­ Advancing Research in Medicinal Uses of Marijuana, Webinar Broadcast juana states (reporting data from 19 of the 23 states and Washington (july 17,2014} (NIDA and AESTown Hall) (NIDA and FDA discussing DC}). potential medical and therapeutic uses of cannabis); Volkow, "Marijuana 24. Colo. Canst. art. XVI11, § 14; Colo. Canst. art. XVIII,§ 16(1}(a); Letter fiom the Director, NIDA" (April2015) (there is mounting anecdotal 1 CCR § 212-2.402(B). evidence for the efficacy of marijuana-derived compounds}. 25. CDPHE, "Medical Marijuana Registry Program Update" (March 11. HR 499, Ending Federal Marijuana Prohibition Act of2013 (lim­ 31, 2015), www.colorado.gov/pacifidsites/default/fil es/03 _201 5_ % 20 iting applicability ofCSA to marijuana); HR 501, Marijuana Tax Equity MMR_report_draft.pdf(CDPHE MMJ Reg.). Act of 2013 (imposing a federal excise tax on marijuana sales and require 26.5 CCR §§ 1006-2:2(A)(3) and 2:6. obtaining a permit &om the Department of the Treasury); HR 689, States' 27. 5 CCR § 1006·2:2(B). St:e also CDHPE, "Application for Regis­ Medical Marijuana Patient Protection Act (requiring rescheduling mari· tration Card for Patients Under 18 Years of Age" (Nov. 2014), www.colo juana, but not as Schedule I or II, and transferring the control over access rado.gov/pacific/sites/default/files/MMR1002-Minor%20Application· to marijuana for research purposes, which is currcndy the responsibility of 110114.pd£ NIDA, to a component of the NIH, HHS to an entity "that is not focused 28. Colo. Canst. art. XVIII,§ 16(1)(a); 1 CCR § 212-2.402{B). on researching the addictive properties ofsubstances "); HR 710, Truth in 29. DO], "Investigations and Prosecutions in States Authorizing the Trials Act (affirmative defense for conduct relating to medical marijuana Medical Use of Marijuana," www.justice.gov/opalbloglmemorandum­ use}; HR 1523, Respect State Marijuana Laws Act of2013 (providing selected-united-state-attomc:ys·invcstigations-and-prosccutions-states: that the marijuana provisions of the CSA do not apply to any person act­ [P]riorities should not focus federal resources in your States on indi- ing in compliance with state Jaws); HR 1635, National Commission on viduals whose actions are in clear and unambiguous compliance with Federal Marijuana Policy Act of2013 (creating a federal commission to existing state laws providing for the medical use of marijuana. For review federal policies regarding marijuana}; HR 5226, the Charlotte's example, prosecution of individuals with cancer or other serious ill­ Web Medical Hemp Act of2014 (amending the CSA to exclude them· nesses who use marijuana as part of a recommended treatment regimen peutic hemp and CBD from the definition of marijuana and any con­ consistent with applicable state law, or those caregivers in clear and trolled substance classification); S 1333, Therapeutic Hemp Medical unambiguous compliance with existing state law who provide such Access Act of2015 (excluding CBD and CBD-rich plants from the defi­ individuals \vith marijuana, is unlikely to be an efficient use of limited nition of marijuana). federal resources. 12. Su gmerally Bonnie and Whitebread, Th~ Marihuana Con'Uiction St:t:, t:.g., Fine, Too High to Fail111, 112 {2012); Reilly, "Obama's Drug (1974). Set: also California Poison Act, Title 419 § 2723(8) (1913), War: After Medical Marijuana Mess, Feds Face Big Decision on Pot," T~ ("extracts, tinctures, or other narcotic preparations of hemp, or loco-weed, Huffington Post (Jan. 26, 2013), www.huffingtonpost.com/2013/01/26/ their preparations or compounds"); the Uniform State Narcotic Drug Act obamas-drug~war-medical~marijuana_n_2546178.html.

The Colorado Lawyer 1 October 2015 1 Vol. 44, No. 10 79 CANNABIS LAWS AND RESEARCH AT COLORADO INSTITUTIONS OF HIGHER EDUCATION

30. Cole Memo I, supra note 3. the contrary, and that local use affects supply and demand in the national 31./d marijuana market). 32. DOJ Financial Guidance, supra note 3; FmCEN Guidance, supra 43. Coats v. Dish Nttwork ILC, 2015 CO 44 at 118, 350 P.Jd 849, 852 note 3. (2015). 33. DEA, MThe DEA Position on Marijuana" 1, 5 (2013) {"Marijuana 44./d. is properly characterized under Schedule I of the Controlled Substances 45. Brief for Respondent at 20, Nebraska and Oklahoman Colorado, No. Act. ...The clear weight of the currently available evidence supports this 220144 2015 (citing Raith, 545 U.S. at 29). classification, including evidence that smoh:d marijuana has a high poten­ 46. 21 USC § 801(2); DEA, "The DEA Position on Marijuana" 5, tial for abuse, has no accepted medicinal value in treatment in the United (2013), wwwJustice.gov/dea/docs/marijuana_position_2011.pdf. St:Jtes, and evidence that there is a general lack of accepted safety for its As ofJanuary 2013,125 researchers registered with DEA to perform use even under medical supervision."). studies with marijuana, marijuana extracts, and non· tetrabydro· 34. Devinsky tl a!., "Cannabidiol: Ph:umacology and Potelltial Thera­ cannabinol (THC) marijuana derivatives thllt exist in the plant, such peutic Role in Epilepsy and Other Neuropsychiatric Disorders," 55 as cannabidiol and cannabinol. The Studies include evaluation of abuse Epiltpsia 791,791-802 (2014). Su also Young, "Marijuana Stops Child's potential, physical/psychological effects, adverse effects, therapeutic Seven: Seizures," CNN (Aug. 7, 2013), www.cnn.com/2013/08/07/health/ potential, and detection. Eighteen of the researchers are approved to charlotte-child-medical-marijuana. conduct research with smoked marijuana on humans. 35.41 USC §§ 701,702, and 706 (A "drug·fu:e workplace"is defined as 47. NIDA, "Rese:U'Ch on the Therapeutic Benefits of Cannabis and "a site for the performance of work done in connection with a specific Cannabinoids," www.drugabuse.gov/drugs·abuse/marijuana/nida­ grant or contract ... at which employees ofsuch entity are prohibited from research-therapeutic-benefits-cannabis·cannabinoids. engaging in the unlawful manufacture, distribution, dispensation, posses­ 48. Ste generally Manchikanti, "A Systematic Review of Randomized sion, or use of a controlled substance in accordance with the requirements Trials of Long-Term Opioid Management for Chronic Non-C!lllcer of this Act."). Pain,"14 Pain Physician 91 (2011). 36. Pub. L. No.100+690 § 513 (1988}; 34 CFR § 84 (2015}. 49. NIDA, "Marijuana Research at NIDA,"www.drugabuse.gov/mari 37.20 USC § l145g; 34 CFR § 86.1 (2014)(mandating that institu­ juana·research-nida. tions ofhigher education put into place "standards ofconduct that clearly 50. FDA, "FDA and Marijuana" (March 3, 2015), www.fda.gov/News prohibit, at a minimum, the unlawful possession, use, or distribution of Events!PublicHealthFocuslucm421163.htm. illicit drugs and alcohol by students and employees on its property or as 51. Su gtn"ally NIDA, "NIDA's Role in Providing Marijuana for part ofits activities"). Rese:U'Ch" (March 2015), www.drugabusc.gov/drugs-abuse/marijuana/ 38. The Bank Secrecy Act is the common name for the statutes and nidas-role-in·providing--marijuana•research. regulations dealing with money laundering and counterterrorism. Ste 31 52. 21 CFR § 312.22(a}; 21 USC § 823(£); 21 CFR § 1301.18. &t also USC § 310; Pub. L. No. 91-508 (1970). The American Bankers Associa­ Announcement of Revision to the Department of Health !llld Human tion addresses the matter succinctly: Services Guidance on Procedures for the Provision ofMarijuana forMed· All banks are subject to federal law, whether the bank is a national bank ical Research as Published on May 21,1999. Fed. Reg. 80, 120} (June 23, or state-chartered bank. At a minimum, all banks maintain federal 2105). deposit insurance which requires adherence to federal law. Violation of 53./d. federal law could subject a bank to loss ofits charter• ... All banks are 54.21 USC § 823{£) and (m); 21 CFR § 1301.18. Ste gmerally NIDA, subject to the requirements of the BSA. Under the BSA, banks must "NIDA Drug Supply Program" (June 2015), www.drugabuse.gov/research report to the federal government any suspected illegal activity which erslresearch-resourccs/nida-drug-supply-program. would include any transaction associated with a marijuana business. 55.21 CFR § 1301.18. See generally NlDA,npm note 51. American Bankers Association, "FAQ: (Feb. 2014}. 56. See, e.g., FDA, wMarijuana Research with Human Subjects" (Oct. 39. Ste gennrzlly 18 USC §§ 1956 and 1957 (federal anti-money-laun­ 2014), www.fda.gov/NewsEvents/PublicHealthFocuslucm421173.htm. dering st:Jtutes),1956 (b) (a person who conducts a financial transaction 57. 7USC § 5940. "knowing that the property involved ... represents the proceeds of some 58. Colorado law also permits hemp research at institutes of higher form of unlawful activity," may be imprisoned and fined the greater of learning, but the definition ofMrescarch and development" mirrors the S500,000 or twice the value of the property involved), 1956(a)(1)(B) (to Farm Bill. 8 CCR § 1203-23:1 (growth ofhemp either by an institution of show money laundering, the government must prove that there was a higher education or under a pilot program administered by the Depart­ financial transaction, the funds were the proceeds ofunlawful activity, the ment for purposes ofagricultural or academic research in the development institution knew that the proceeds were from unlawful activity, and the of growing industrial hemp). financial transaction was designed to conceal the nature, location, source, 59. Soukhanov et al, eds .• ~hst"s llNtW Rivaside Uni'Vmity Diction­ ownership, or control of the proceeds). ary69(1984). 40. 18 USC § 2 (a person who "aids, abets, counsels, commands, in­ 60.21 usc§ 355. duces or proc:ures" any federal crime "is punishable as a principal" giving 61. The Consolidated and Further Continuing Appropmtions Act, rise to the same consequences as the underlying crime). A person or or· 2015 § 539 ("None ofthe funds made available by this Act may be used in ganization "who aids and abets money laundering is criminally liable as a contravention ofsection 7606 (Legitimacy oflndustrial Hemp Research) principal, and the government's burden to show aiding and abetting re· of the Agricultural Act of2014 (Public Law 113-79) by the Department quires that the defendants 'associated themselves with the venture, partic­ ofJustice or the Drug Enforcement Administration."). ipated in it as in something they wished to bring about, and sought by 62. The CSA's definition of marijuana "does not include the mature their actions to make it succeed.'" U.S. v. Shmnan,262 F.3d 784,794 (8th stalks ofsuch plant, fiber produced from such st:Uks, oil or cake made from Cir. 2001) (quoting U.S. v.Aiwrtz, 987 F.2d 77,83 (1st Cir.1993}}. the seeds ofsuch plant, any other compound, manufacture, salt, derivative, 41. DOJ Financial Guidance, supra note 3. mixture, or preparation of such mature stalks (except the resin extracted 42. U.S. v. Oakland Cannabis Buyers' Coop., 532 U.S. 483, 495, 499 therefrom), fiber, oil, or cake, or the sterilized seed ofsuch plant which is (2001) (holding that Congress has the right to regulate marijuana and incapable ofgermination."21 USC§ 802(16). may criminalizc: the production and use of cannabis even where states 63.21 CFR § 1308.35. See also Hemp /ndustritsAu'n "· DEA, 357 F. 3d approve its use for medicinal purposes}; Gonules v. Rairh, 545 U.S. 1 1012,1018 (9th Cir.2004): (2005) (holding that the commerce clause gave Congress authority to Congress was aware of the presence of trace amounts of psychoactive prohibit the local cultivation and use of marijuana, despite state law to agents (later identified as THC) in the resin of non-psychoactive hemp

80 The Colorado Lawyer I October 2015 I Vol. 44, No. 10 CANNABIS LAWS AND RESEARCH AT COLORADO INSTITUTIONS OF HIGHER EDUCATION

when it passed the 1937 "Marihuana Tax Act," and when it adopted ulc I drug as well as the continuing controversy as to whether or not the Tax Act marijuana definition in the CSA. As a result, when Con­ cannabis is of medical value are obstacles to medical progress in this area. gress excluded from the definition of marijuana "mature stalks ofsuch Based on evidence currently available the Schedule I classification is not plant, fiber ... , [and] oil or cake made from the seeds,~ it also made an tenable; it is not accurate that cannabis has no medical value, or that infor­ exception to the exception, and included "resin extr.l.ctcd from" the mation on safety is lacking." excepted parts of the plant in the definition of marijuana, despite the 74. Hall, "What has Research Over the Past Two Decades Revealed stalks and seeds exception. About the Adverse Health Effects of Recreational Cannabis Usc?" 110 As an aside, CBD docs not meet this exception. In the CSA, Congress Addicthm 19-35 (Oct. 7, 2014}. Set also Walton, "What 20 Years Of deliberately included any "resin,''"every compound," and "preparation" of Research Has Taught Us About The Chronic Effects Of Marijuana," the cannabis plant in the definition of marijuana, effectively capturing Forhts (Oct. 7, 2014), www.forbes.com/siteslaliccgwalton/2014/10/07/ CBD; accordingly, CBD does not fall in the statutory or regulatory exclu­ what-20-years-of-rescarch-has-taught-us-about-the-chronic·effects-of­ sions and, in spite of not having psythoactive properties, remains regulated marijuana ("Given that Colorado and Washington State have decided to as a Schedule I substance under the CSA. legalize, the governments in these states should aim to regulate sales in 64.21 CFR § 170.30(b) and {c) and 170.3((}. ways that minimize the harms arising from use. This should certainly 65.21 CFR § 1308.35(a){2). include informing users about the risks ofusc and doing what is possible 66. FDA, "FDA and Marijuana: O!Jestions and Answers" {June 2015), to discourage uptake by adolescents."}. www.fda.gov/NewsEvents!PublicHealthFocuslucm421168.htm#dictary 75. Filbey tt al "Long-term Effects of Marijuana Use on the Brain," suppl. PNAS, m.pnas.orglcontentl111/47/16913.full.pdf{ "Our findings provide 67. NIDA Federal Approved Source, supra note 22 evidence that heavy, chronic marijuana users have lower OFC gray mat­ 68. Colo. Const. art. XVUI, § 16 {1)(a} and (b) (taxed and regulated in ter volumes compared with non using conttols. "). manner similar to alcohol); CRS § 12-43.4; CCR § 201 -18. 76. ProCon.org, "60 Peer-Reviewed Studies on Medical Marijuana" 69. Editorial, "Marijuana Research Current restrictions on Marijuana {2015), mcdicalmarijuana.procon.orglview.resource.php?resourcciD• Research are Absurd," SrimtificAmmran (Nov. 22,2004}, www.scientific 000884. american.com/articlelmarijuana-rescarch. 77./d. 70. Ste, e.g., Remington, "Marijuana Market One of the Country's 78./d, Fastest Growing, Hindered by Federal Raids,'' Reason. com (Nov. 8, 2013), 79./d. rcason.com/blog/2013/11/08/report-marijuana-market-onc-of-the­ 80. &t, t.g., Perrone, "The Junk 'Science' Behind the Marijuana Legal­ count; Fidclman, "Why Legalizing Medical Marijuana Will Make ization Movement," TIM Washington Post {Oct. 20, 2014) (indicating the Investors Extremely Wealthy," Forbes (Nov. 04, 2014), www.forbes.com/ intensive studies are lacking, particularly in respect to casual users). sites/markfidelman/2014/11/04/why-legalizing-medical-marijuana-will­ 81. Su, t.g., Castle tt al, eds., Marijuana and Madness 17,23 (2d ed., mak.e-investors·extremely-wealthy; Kester, "The Pot Industry Puts on a 2012). Su abo Mehmedic tf al , "Potency Trends of A1-THC and Other Tie, As Marijuana Becomes Legal, Businesses Look for Managers Who Cannabinoids in Confiscated Cannabis Preparations from 1993 to 2008," Know the Ropes," Tht Wall Strut] (July 15, 2014), blogs.wsj.com/cfo/ 5J Formsic Srimct 1209, 1209 (2010). 2014/07/15/pot-industry·puts·on-a-tie. 82. Today, the convention for molecules derived from resin of the 71. ArcView Market Research estimates that the current United States cannabis plant is "phyrocannabinoids.""Synthetic cannabinoids" are those legalized cannabis market was valued at S1.53 billion in 2013 and S2.6 bil­ that have been man-made. "Endocannabinoids" refers to natural cannabi­ lion in 2014, and is poised to grow to S102 billion in 2018. Arc View Mar­ noids found in the human body. ket Research, "The State of Legal Marijuana Markets" (2d ed., 2013}; In 83. Mehmedic, supra note 81 at 1209. 2010, the Rand Corporation estimated the recreational, legal, and illegal, 84. Mandai, "Cannabinoid Receptors" (June 2, 2014), www.news-med marijuana market to be valued at S30 to $60 billion. Kilmer et a/., Rand ical.netlhealth/Cannabinoid-Receptors.aspx. Corporation, wWhat America's Users Spend on 1llegnl Drugs: 2000-2010" 85.Interview with Kent Hutchison, professor ofpsythology and neuro­ 4 (Feb. 2014), www.whltehousc.gov/sitesldcfuultlfilcslondcp/policy-and­ science, University of Colorado (April28,2015). research/wausid_rcsults_report.pdf, Barrott, "How to Invest in Dope," Tht 86. St~ National Cannabis Prevention and Information Center ofAus­ N('W York TimtS (June 25, 2013), www.nytimes.com/2013/06/30/maga­ tralia, "C:mnabinoids" (July 1, 2008), ncpic.org.aulprofessionals/publica zinelhow-to-succecd-in-the-legal-pot·busincss.html?pagcwantedo:all tionslfactsheets/cannabinoids. &_r-0. Stt also Maxfield, "The Business of Legal Marijuana: People Are 87. Hutchison,supm note 85. Getting Rich. Should You Get In?" The Motlty Fool (Jan.12, 2014}, www. 88. NIDA and AES Town Hall, supra note 10. Stt also FDA, "Pharma­ fool.comfmvestinglgencral/2014/01/12/the-cconomics-of-marijuana.aspx ceutical Qyality/Manufacturing Standards" (May 5, 2015), www.fda.gov/ (discussing that costs per pound are 1800 and retail sale price are S3,000 Drugs!GuidanceComplianceRegulatorylnformation/Guidances/ucm064 per pound). 971.htm. 72. Su, e.g., American Medical Association (AMA), "H-95.952 89. Winter, "Weed Control, Research on the Medicinal Benefits of Cannabis for Medicinal Usc" (2009) (In 2009, the AMA resolved that Marijuana may depend on Good G.udcning-and Some Say Uncle Sam, marijuana's status as a federal Schedule I conttolled substance be reviewed the Country's Only Legal Grower of the Cannabis Plant, Isn't Much ofa with the goal of fucilitating the conduct of clinical research and develop­ Green Thumb," Boston Globt (May 28, 2006); Nelson, "The End of Ole ment ofcannabinoid-based medicines; it also urgerl the NIH "to develop a Miss' Pot Monopoly?" US Nt'WS (Aug. 28, 2014). special schedule" for cannabis, but it was critical of the state marijuana 90. Halper, "Mississippi, Home to Federal Government's Official Stash regimes). Stt also Hall, "What Has Research Over the Past Two Decades ofMarijuana," Tht LosAngtlts Times (May 28, 2014). Revealed About the Adverse Effects of Recreational Cannabis Usc?" 110 91. CRS § 12-43.4-202(3)(a)(IV)(B) ("Testing shall include, but not Addition 19-35 {2015). be limited to, analysis for residual solvents, poisons, or toxins; harmful 73. Grant tf a!., "Medical Marijuana: Clearing Away the Smoke," 6 chemicals; dangerous molds or mildew; filth; and harmful microbials such Open Neurology].l8-25 (2012), www.ncbi.nlm.nih.gov/pmc/articlcsl as E. Coli or salmonella and pesticides."); 1 CCR § 212·2.1006{C)(4) PMC3358713/#RS9. The University ofCalifornia San Diego's Center for (requiring label to display whether the product was testing for contami­ Medicinal Cannabis Research, a California state· funded research project nants, including mold, mildew, filth, microbials, herbicides, pesticides, that conducted various clinical trials using NIDA-sourccd marijuana, con­ fungicides, and harmful chemicals for Harvest Batch products; residual cludes, "Evidence is accumul:uing that cannabinoids may be useful medi­ solvents, poisons, toXins, microbials, molds, mildew, and filth for Produc­ cine for certain indications . . .. The classification of marijuana as a Schcd· tion Batch products}.

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92.1 CCR § 212·2.701{C). 101. Letter from Colorado Attorney General to Departments ofHealth 93.1 CCR § 212-2.703{A). and Human Services and Education, NIDA, and NIH (Dec. 18, 2014). 94. CRS § 12-43.4-202{3)(a){VII){F) and (K); 1 CCR §§ 212· 102. CRS § 25-1.5-110 ("The department shall monitor changes in 2.1006{C){2)(c) and (C)(5) (labeling of retail marijuana products}; 1 CCR drug use patterns, broken down by county and race and ethnkity, and the § 202-2.1004.5{B)(4)(b)(ii) (liquid edible retail marijuana products). emerging science and medical information relevant to the health effects 95.CRS § 25-1.5-106. associated with marijuana usc."). 96. CRS § 25-1.5-106.5 {describing the duties delegated to the 103. CDPHE, "Monitoring Health Concem5 Related to Marijuana in CDPHE with respect to medical marijuana resean:h). Colorado: 2014" (Jan. 12, 2015), www.colorado.gov/pacific/cdphe/moru 97. CDPHE, "ApproV~:d Medical Marijuana Rcsean:h Gmnts,"'www. toring·marijuana-related-health-etfccts. colorado.gov/paci6c/cdphe/approvcd-mcdical-marijuana-rcsearch·grants. 104. Volkow, supra note 10; NIDA, "DrugFacts: ls Marijuana Medi­ 98. lntervicw with Ken Gershman, CDPHE Medical Marijuana cine?" {April 2015), www.drugabuse.gov/publications/drugfacts/mari Grant Manager (May 5, 2015). juana·medicine (srudies show that marijuana extr.lcts help kill cen:Un can­ 99.1nterview with Rick Dublin, ExecutiV~: Director, MAPS (May 12, cer cells and reduce the size ofothers), www.drugabuse.gov/pllblications/ 2015). drugfuctslmarijuana-medicine; NIDA and AES Town Hall, supra note 10 100. CRS § 25-1.5-106(1) and (5). {indicating that CBD potentially has positiVI: health benefits in connec· tion to the treatment ofepilepsy ). •

QUESTIONS

1. Short answer: Explain why conducting research on or with 5. In Colorado, how may a minor obtain marijuana legally? cannabis at federally funded institutions of higher learning is a. from specially designated dispensaries challenging. b. from her parent or legal guardian, as long as the person is also a registered caregiver 2. To what can the rapid growth of the marijuana industry in the c. with recommendations from two Colorado doctors and United States be attributed? parental approval a. DOJ memoranda to U.S. attorneys d. with mere approval from the Colorado Department ofPublic b. University of Mississippi research about the benefits of can­ Health and Environment nabis c. the Bank Secrecy Act of1970 6. Which federal agency has provided guidance connected to the d Colorado Amendment 64 scope of the Agricultural Act of 2014, Legitimacy oflndustry Hemp Research? 3. What rationale does the federal govemment use for limiting the a. Drug Enforcement Agency source of marijuana for federally approved research to the Uni­ b. Department ofjustice versity of Mississippi? c. Department of Agriculture a. FDA requirements d. Department ofEducation b. express intent ofCongress e. none c. lobbying efforts d. international treaty 7.How can researchers at federally funded institutions ofhigher education conduct research with marijuana using human sub­ 4. Which of the following substances are not classified as Sched· jects without a Schedule I license? ule I substances, the most restrictive category ofcontrolled sub­ a. clinical trials using marijuana purchased legally under state law stances under the Controlled Substance Act? b. clinical trials using synthetic cannabinoids a. marijuana c. observational studies b. opium d. personal self-administration studies-i.e., researchers person­ c. methamphetamine ally consume marijuana and study themselves d. cocaine e.c and d. Anrwm on page 89. f. b,c,and d

82 The Colorado Lawyer I October 2015 I Vol. 44, No. 10