throbber
NO. 20 148
`
`In the
`Supreme Court of the United States
`
`MARVIN WASHINGTON DB, AS PARENT OF INFANT AB
`JOSE BELEN SC, AS PARENT OF INFANT JC AND
`CANNABIS CULTURAL ASSOCIATION, INC.,
`
`
`
`Petitioners,
`
`v.
`
`WILLIAM PELHAM BARR, IN HIS OFFICIAL CAPACITY
`AS UNITED STATES ATTORNEY GENERAL UNITED STATES
`DEPARTMENT OF JUSTICE TIMOTHY J. SHEA, IN HIS OFFICIAL
`CAPACITY AS ACTING DIRECTOR OF THE DRUG ENFORCEMENT
`ADMINISTRATION, UNITED STATES DRUG ENFORCEMENT
`ADMINISTRATION, AND THE UNITED STATES OF AMERICA,
`
`
`
`Respondents.
`
`On Petition for a Writ of Certiorari to the
`United States Court of Appeals for the Second Circuit
`
`BRIEF OF AMICI CURIAE
`CReDO SCIENCE THE AMERICAN JOURNAL OF
`ENDOCANNABINOID MEDICINE ETHAN RUSSO, M.D.
`AND JAHAN MARCU, Ph.D. IN SUPPORT OF PETITIONERS
`
`
`
`
`
`
`DAVID KOTLER
` COUNSEL OF RECORD
`HOBAN LAW GROUP
`730 17TH STREET
`SUITE 420
`DENVER, CO 80202
`(303) 674 7000
`DAVIDK@HOBAN.LAW
`
`SEPTEMBER 14, 2020
`
` COUNSEL FOR AMICI CURIAE
`
`SUPREME COURT PRESS ♦ (888) 958 5705 ♦ BOSTON, MASSACHUSETTS
`
`

`

`i
`
`QUESTION PRESENTED
`
`Whether the court should grant Petitioners Marvin
`Washington, DB, as parent of infant AB, Jose Belen,
`SC, as parent of infant JC, and Cannabis Cultural
`Association, Inc. (“Petitioners”) Writ of Certiorari to
`determine whether the federal scheduling and
`criminalization of marijuana based on 21 USC § 812,
`without exception, violates the Due Process Clause
`of the Fifth Amendment to the U.S. Constitution and
`whether the requirement that an injured party must
`first exhaust administrative remedies to seek relief is
`consistent with the Due Process Clause of the Fifth
`Amendment.
`
`
`
`
`
`

`

`ii
`
`TABLE OF CONTENTS
`
`Page
`
`QUESTION PRESENTED .......................................... i
`
`TABLE OF AUTHORITIES ...................................... iii
`
`INTERESTS OF AMICI CURIAE ............................. 1
`
`SUMMARY OF ARGUMENT .................................... 4
`
`ARGUMENT ............................................................... 6
`
`I. LEGAL BACKGROUND ......................................... 6
`
`II. THE FEDERAL SCHEDULING OF MARIJUANA
`UNDERMINES PUBLIC HEALTH .......................... 6
`
`a. The Federal Status of Marijuana Impedes
`Upon Scientific Research and Obstructs
`the Publishing of Findings ......................... 7
`
`b. Advocates and Opponents Agree that
`Rescheduling will not resolve the Obstacles
`Researchers Face ...................................... 12
`
`CONCLUSION .......................................................... 14
`
`
`
`
`
`
`
`

`

`iii
`
`TABLE OF AUTHORITIES
`
`Page
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Washington v. Barr,
`925 F.3d 109 (2d Cir. 2018) ................................. 4
`
`CONSTITUTIONAL PROVISIONS
`
`U.S. Const. amend. V ............................................... i, 5
`
`STATUTES
`
`21 U.S.C. § 802 ............................................................ 1
`
`21 USC § 812 ................................................................ i
`
`21 USC § 812(b)(1) ...................................................... 7
`
`JUDICIAL RULES
`
`Sup. Ct. R. 37 ............................................................ 1
`
`OTHER AUTHORITIES
`
`A. Mead,
`Legal and Regulatory Issues Governing
`Cannabis and CannabisDerived Products
`in the United States , FRONT PLANT
`SCIENCE, 10 (2019) .............................................. 8
`
`A. Mead,
`The Legal Status of Cannabis (Marijuana)
`and Cannabidiol (CBD) Under U.S. Law,
`EPILEPSY & BEHAVIOR, 70 (May 2017) .................. 8
`
`

`

`iv
`
`TABLE OF AUTHORITIES – Continued
`
`Page
`
`A.J. Soroosh, R. Henderson,
`L. Dodson, C.S. Mitchell, J.W. Fahey,
`Mitigating Potential Public Health
`Problems Associated with Edible Cannabis
`Products Through Adequate Regulation a
`Landscape Analysis, CRITICAL REVIEWS IN
`FOOD SCIENCE AND NUTRITION, 1 (2020) ........... 12
`
`Bertha Mardas,
`5 Reasons Marijuana is Not Medicine,
`THE WASHINGTON POST, (April 29, 2016),
`https //www.washingtonpost.com/news/in
`theory/wp/2016/04/29/5 reasons
`marijuana is not medicine/ ............................... 13
`
`C.G. Perrine, C.M. Pickens, T.K. Boehmer,
`B.A. King, et al., Characteristics of a
`Multistate Outbreak of Lung Injury
`Associated with ECigarette Use, or
`Vaping—United State, MORBIDITY
`MORTAL WEEKLY REPORT, 68 (2019) ................. 10
`
`C.M. Bowling, A.Y. Hafez, S.A. Glantz,
`Public Health and Medicine’s Need to
`Respond to Cannabis Commercialization
`in the United States A Commentary,
`JOURNAL OF PSYCHOACTIVE DRUGS (2020) .... 8, 11
`
`Chris Roberts,
`Prohibitionist Group CoFounder Backs
`Reclassifying Marijuana in Congressional
`Bid, MARIJUANA MOMENT, (January 26,
`2020), https //www.marijuanamoment.net/
`wife of prohibitionist group co founder
`backs reclassifying marijuana in
`congressional bid/ .............................................. 13
`
`

`

`v
`
`TABLE OF AUTHORITIES – Continued
`
`Page
`
`E.B. Russo, M.L. Mathre, A Byrne, R Velin, PJ
`Bach, J Sanchez Ramos, et al., Chronic
`Cannabis Use in the Compassionate
`Investigational New Drug Program an
`Examination of the Benefits and Adverse
`Effects of Legal Clinical Cannabis,
`JOURNAL OF CANNABIS THERAPEUTICS, 2 1
`(2002) ................................................................... 9
`
`EB Russo,
`Current Therapeutic Cannabis
`Controversies and Clinical Trial Design
`Issues, FRONT PHARMACOL, 7 309 (2016) ............ 9
`
`J. Marcu,
`Regulators Need to Rethink Restrictions
`on Cannabis Research, NATURE, 572 (2019).. 8, 10
`
`Kyle Jaeger,
`Formerly AntiMarijuana Congressman
`Cosponsors Comprehensive Legalization
`Bill, MARIJUANA MOMENT, (January 9,
`2020), https //www.marijuanamoment.net/
`formerly anti marijuana congressman
`cosponsors comprehensive legalization
`bill/ ..................................................................... 13
`
`M.O. Bonn Miller, M.J.E. Loflin,
`B.F. Thomas, J.P. Marcu, et al., Labeling
`Accuracy of Cannabidiol Extracts Sold
`Online, JAMA, 318 (2017) ................................. 10
`
`RC Randall,
`Marihuana A Signal of Misunderstanding
`First Report (1972)............................................... 7
`
`

`

`vi
`
`TABLE OF AUTHORITIES – Continued
`
`Page
`
`RN Bloor, TS Wang, P Spanel, D Smith,
`Ammonia Release from Heated ‘Street’
`Cannabis Leaf and Its Potential Toxic
`Effects on Cannabis Users, ADDICTION,
`103 10 (2008) ........................................................ 9
`
`Russo EB, Mead AP, Sulak D.,
`Current Status and Future of Cannabis
`Research, CLINICAL RESEARCHER
`(April 2015) ........................................................... 8
`
`United States Drug Enforcement
`Administration, Marijuana, Medicine &
`the Law (Vol. 1 1988) .......................................... 7
`
`
`
`
`
`

`

`1
`
`
`
`INTERESTS OF AMICI CURIAE
`
`Pursuant to Supreme Court Rule 37, CReDO
`Science, the American Journal of Endocannabinoid
`Medicine, Ethan Russo, MD, and Jahan Marcu, Ph.D.,
`respectfully submit this brief amicus curiae in support
`of petitioner.1
`
`CReDO Science (“CReDO”) is an intellectual prop
`erty holding company researching cannabis2 and
`the endocannabinoid system. CReDO focuses on non
`tetrahydrocannabinol (“THC”) cannabis chemical
`varieties, hemp derived nutritional supplements and
`endocannabinoid system related diagnostics.
`
`The American Journal of Endocannabinoid Medicine
`(“AJEM”) is a U.S. based peer reviewed scientific publi
`cation with a print circulation of over 45,000. The
`AJEM, is the first and only American medical authority
`committed to scientific study of the endocannabinoid
`
`1 Pursuant to Rule 37.2, all parties with counsel listed on the
`docket have consented to this brief’s filing and their respective
`counsel have received notice at least 10 days prior to the due
`date of the Amicus Curiae’s intention to file this brief. Letters
`evidencing such consent have been filed with the Clerk of the
`Court. Pursuant to Rule 37.6, Amicus Curia affirm that no counsel
`for any party authored this brief in whole or in part and no counsel
`or party made a monetary contribution intended to fund this
`brief’s preparation or submission. No person other than Amicus
`Curiae, its members or counsel made a monetary contribution
`to its preparation or submission.
`
`2 This amicus brief refers to both “cannabis” and “marijuana.” The
`term “cannabis” is used to refer to the genus family Cannabis
`Sativa L.. The term “marijuana” is used as defined pursuant to 21
`U.S.C. § 802(16).
`
`

`

`2
`
`system. The objective of the AJEM is to help educate
`medical professionals about the role of the endocan
`nabinoid system in homeostasis, as a therapeutic
`target for cannabis and cannabinoid prescription,
`and non prescription products. AJEM aims to present
`the currently available authoritative research, while
`stimulating questions regarding the role of medical
`cannabis in all forms, as a growing methodology in
`the field of treatment and patient care. The intent of
`AJEM is to be utilized as a clinical resource and
`contribute to the examination and overall scientific
`discussion of the endocannabinoid system.
`
`Ethan Russo, M.D., is a Clinical Child and Adult
`Neurologist, Adjunct Associate professor of pharmacy
`at the University of Montana, former editor of the
`Journal of Cannabis Therapeutics, former president
`of the International Cannabinoid Research Society,
`and former chairman of the International Association
`for Cannabinoid Medicines. In 1999, Dr. Russo obtained
`approval from the Food and Drug Administration
`(“FDA”) (IND #58,177) to conduct a human pilot study
`to research the risk and benefits of smoked cannabis in
`patients suffering from treatment resistant migraines.
`Despite FDA approval, Dr. Russo was unable to con
`duct this research because the National Institute of
`Drug Administration (“NIDA”) refused to sell any of
`its cannabis to him. Dr. Russo has worked for foreign
`companies for 14 years, 11 of which as the Senior
`Medical Advisor, Medical Monitor and Study Physi
`cian to GW Pharmaceuticals in 23 Phase I III clinical
`trials in the development programs of Sativex®, nabixi
`mols, and Epidiolex®. Dr. Russo currently serves as
`CReDO Science Founder and Chief Executive Officer
`(“CEO”) and Senior Medical Advisor to Andira Pharma
`
`

`

`3
`
`ceuticals, a Canadian based company developing phar
`maceutical products from cannabis designed to treat
`metastatic cancer and antibiotic resistant “superbug”
`bacterial infections including as vancomycin resistant
`Enterococcus (“VRE”) and methicillin resistant Staphy
`lococcus aureus (“MRSA”).
`
`Jahan Marcu, Ph.D. has over 15 years of cannabi
`noid research, policy, and operations experience, and
`is also among a select group of professionals globally
`that has earned a Ph.D. focused on the endocannabi
`noid system with research on cannabinoid receptors’
`structure and function and endocannabinoid system
`molecular pharmacology and role in bones. Currently
`serving as American Journal of Endocannabinoid Medi
`cine Editor In Chief, Dr. Marcu is also the co founder
`and former Chief Science Officer of the International
`Research Center on Cannabis and Health’s (also known
`as the Institute of Cannabis Research), founder and
`former chair of the American Chemical Society’s Can
`nabis Chemistry sub division (the world’s largest and
`oldest professional scientific society), and has served
`on multiple expert government advisory and trade
`association committees, as well as scientific organiza
`tions including ASTM (D37 Subcommittee chair), past
`chair of the AHPA Cannabis committee, ACS Cannabis
`Chemistry Subdivision (“CANN”), AOCS, AOAC, IACM
`(past BOD), and co founder of IMCPC.
`
`Dr. Marcu’s work has been instrumental to facili
`tating and supporting fact based, scientific approaches
`vital to the industry and patients including research
`focused on solving cannabinoid receptors structure and
`function, cannabis compounds’ anti cancer properties,
`and method development and validation for analyzing
`complex formulations. Dr. Marcu’s efforts include
`
`

`

`4
`
`developing international certification and training
`programs, co authoring American Herbal Phar
`macopeia’s Cannabis Quality Control and Therapeutic
`Monographs, and, as chair of the American Herbal
`Products Association (“AHPA”) cannabis committee,
`co creating the first industry standards. Dr. Marcu
`participated in the co development of a biotech appli
`cation to predict drug interactions between cannabis
`and commonly prescribed pharmaceutical drugs and
`published one of the first CBD products safety studies.
`Honored with the Mahmoud Elsohly award for excel
`lence in cannabis chemistry and the Billy Martin
`research achievement award from the International
`Cannabinoid Research Society for his work on THC
`and CBD synergy in aggressive brain cancers, Dr.
`Marcu is a court qualified synthetic cannabinoid and
`cannabis expert and his work has been published
`and covered in Science, Nature, Journal of the Amer
`ican Medical Association (“JAMA”), the Washington
`Post, and CNN.
`
`
`
`SUMMARY OF ARGUMENT
`
`Petitioners filed a complaint in the United States
`District Court for the Southern District of New York
`for determination that the federal status of marijuana
`as a Schedule I controlled substance under the Con
`trolled Substances Act (“CSA”) is unconstitutional and
`sought an injunction against the enforcement of the
`CSA’s marijuana provisions.3 The district court dis
`missed Petitioners’ complaint for failure to state a claim
`
`3 Washington v. Barr, 925 F.3d 109, 114 (2d Cir. 2018).
`
`

`

`5
`
`and to exhaust administrative remedies.4 The United
`States Court of Appeals for the Second Circuit affirmed
`in part and held that Petitioners were first required
`to exhaust administrative remedies.5 Petitioners now
`seek a writ of certiorari.
`
`Petitioners argue that the federal status of mari
`juana violates the Due Process Clause of the Fifth
`Amendment as it deprives Petitioners access to life.6
`Amici join Petitioners in these arguments.
`
`In addition to Petitioners’ arguments, amici res
`pectfully submit that the Court should grant the writ
`of certiorari because the Schedule I status has created
`obstacles that have been detrimental to America’s
`public health. The federal scheduling of marijuana is
`a matter of significant public concern because the
`Schedule I status prevents researchers from conducting
`marijuana research to gather medical and scientific
`data. U.S. based researchers are unable to study the
`benefits and risks of marijuana use, to explore potential
`uses, and innovate solutions because of the federal
`status. Thus, amici respectfully request that the Court
`grant Petitioner’s Writ of Certiorari.
`
`4 Id. at 114 115.
`
`5 Id.
`
`6 Washington v. Barr, Petition for a Writ of Certiorari, 22 31
`(2020).
`
`

`

`6
`
`
`
`ARGUMENT
`
`I. LEGAL BACKGROUND
`
`Marijuana is classified as a Schedule I controlled
`substance. All Schedule I controlled substances are
`subjected to control limitations in an effort to promote
`public safety. These protective measures, however,
`have impeded, and continue to impede, upon marijuana
`research. Beyond causing a “brain drain,” these mea
`sures hinder the generation of public health data to
`understand the risks and benefits of the marijuana
`products that are available in state legal marijuana
`programs. Rather, the federal status has created
`obstacles for researchers which have had detrimental
`effects on public health and has limited domestic
`drug development.
`
`The federal prohibition and system of criminalizing
`marijuana is irrational and has resulted in regulatory
`agencies abdicating their duty to protect the public
`by halting researchers from developing marijuana
`based medicines and serving other public health needs.
`In order for researchers to be able to study the bene
`fits and risks associated with marijuana use, legal
`pathways must be forged and regulated.
`
`II. THE FEDERAL SCHEDULING OF MARIJUANA UNDER
`MINES PUBLIC HEALTH
`
`Marijuana’s federal status creates significant pub
`lic health concerns as it severely impairs the ability
`to conduct medical and scientific research and the
`publishing of such information. The prohibition of
`marijuana related research has created a knowledge
`
`

`

`7
`
`gap this absence of scientific data amounts to a fail
`ure to protect public health.
`
`a. The Federal Status of Marijuana Impedes
`Upon Scientific Research and Obstructs the
`Publishing of Findings
`
`The federal scheduling of marijuana prevents the
`generation and compilation of data that would be
`useful to guide regulatory agencies and public health
`efforts. The origin of marijuana’s federal status was
`intended to be a placeholder in 1970 when the CSA was
`implemented. The status was pending investigation
`by the Shafer Commission (“Commission”).7 The Com
`mission recommended decriminalizing marijuana for
`medical use, however, President Richard M. Nixon
`vetoed the Commission’s recommendation and politics
`has trumped science since.
`
`Marijuana’s schedule I status prevents research
`and meaningful drug development in the U.S. of mari
`juana derived pharmaceuticals. Schedule I controlled
`substances are defined as substances with high poten
`tial for abuse, no currently accepted medical treatment
`use, and are unsafe, even when prescribed and super
`vised by a physician.8 Researchers consequently face
`onerous regulatory hurdles and must continually advo
`cate on behalf of the collective marijuana industry and
`consumers. As more state legal marijuana markets
`emerge, and as the spectrum of available marijuana
`
`7 United States Commission on Marihuana and Drug Abuse, Mari
`huana A Signal of Misunderstanding First Report, 184 (1972) RC
`Randall, United States Drug Enforcement Administration, Marij
`uana, Medicine & the Law (Vol. 1 1988).
`
`8 21 USC § 812(b)(1).
`
`

`

`8
`
`products diversifies, public health officials must engage
`with the real issue of rapid commercialization and
`press for policies based on public health best prac
`tices.9
`
`In order to conduct research involving Schedule I
`controlled substances, researchers must obtain speci
`fied approvals from the Drug Enforcement Administration
`(“DEA”). DEA approvals impose an extremely difficult
`and time consuming process upon researchers. DEA
`spot inspections, for example, disrupt researcher and
`physician schedules and patient care, lengthy docu
`mentation procedures consume time and resources,
`and onerous storage requirements mirror those for
`highly radioactive or infectious materials. The DEA
`provides no clear guidance to assist Schedule I appli
`cants prepare for the DEA approval inspections of
`their facilities. Further, a legal marijuana program
`licensee is ineligible to obtain DEA approval to conduct
`much needed research despite the resources and exper
`tise they possess. Descheduling and regulation would
`remove the obstacles imposed by the DEA’s onerous
`policies.
`
`9 C.M. Bowling, A.Y. Hafez, S.A. Glantz, Public Health and
`Medicine’s Need to Respond to Cannabis Commercialization in the
`United States A Commentary, JOURNAL OF PSYCHOACTIVE DRUGS,
`1–6 (2020) J. Marcu, Regulators Need to Rethink Restrictions
`on Cannabis Research, NATURE, 572, S19–S19 (2019) Russo EB,
`Mead AP, Sulak D., Current Status and Future of Cannabis
`Research, CLINICAL RESEARCHER, 58 63 (April 2015) A. Mead, The
`Legal Status of Cannabis (Marijuana) and Cannabidiol (CBD)
`Under U.S. Law, EPILEPSY & BEHAVIOR, 70, 288 91, (May 2017)
`A. Mead, Legal and Regulatory Issues Governing Cannabis and
`CannabisDerived Products in the United States, FRONT PLANT
`SCIENCE, 10, 697 (2019).
`
`

`

`9
`
`Furthermore, researchers are limited to use NIDA
`grown marijuana, not products that consumers actually
`purchase and consume. This obstacle centers around
`the monopoly NIDA holds over the available marijuana
`grown for research purposes and the policies in place to
`reinforce the status quo. For example, a NIDA related
`policy restriction is that the University of Mississippi
`scientists selectively breed marijuana to increase its
`biochemical diversity, the cannabis yielded from which
`is less potent in cannabinoid concentration than that
`available in state legal markets and often suffers over
`80% terpenoid loss resulting from long periods of
`storage.10 Additionally, because of the requirement to
`use NIDA cannabis, reproducing positive clinical trial
`results in subsequent pivotal studies is rendered impos
`sible.
`
`As a result, current law prevents American com
`panies from developing cannabis derived pharmaceu
`ticals from a domestic source thereby ceding commer
`cial cannabis pharmaceutical development to foreign
`companies capable of importing pharmaceutical candi
`date drugs into the country where clinical trials occur.
`This is evident for both Sativex® and Epidiolex®. The
`extent of federal marijuana prohibition is unique to
`the U.S. and as a result, marijuana derived pharma
`ceuticals are imported from other countries.
`
`10 EB Russo, ML Mathre, A Byrne, R Velin, PJ Bach, J Sanchez
`Ramos, et al., Chronic Cannabis Use in the Compassionate Inves
`tigational New Drug Program an Examination of the Benefits and
`Adverse Effects of Legal Clinical Cannabis, JOURNAL OF CANNABIS
`THERAPEUTICS, 2 1, 3 57 (2002) RN Bloor, TS Wang, P Spanel,
`D Smith, Ammonia Release from Heated ‘Street’ Cannabis Leaf
`and Its Potential Toxic Effects on Cannabis Users, ADDICTION, 103
`(2008) EB Russo, Current Therapeutic Cannabis Controversies and
`Clinical Trial Design Issues, FRONT PHARMACOL, 7 309 (2016).
`
`

`

`10
`
`To generate meaningful marijuana products data,
`researchers are forced to navigate the obstructions
`imposed by the CSA. Dr. Marcu co authored a first of its
`kind study regarding public health and cannabidiol
`product labeling.11 This study is used by regulators
`to inform consumers and to promote public health
`efforts through accurate labeling of cannabidiol based
`products, which currently lacks due to the absence of
`federal law.12
`
`Descheduling marijuana will allow researchers to
`obtain representative and standardized products that
`will allow studies to be reproduced to provide valuable
`data to guide regulations and public health efforts.
`Despite its federal scheduling, rapid marijuana
`commercialization has outpaced state and federal
`regulatory rulemaking and a myriad marijuana pro
`ducts are quickly becoming available to the public. In
`the absence of federal regulation, this dynamic became
`acutely evident with severe lung disease’s widespread
`appearance in those vaping THC and/or nicotine con
`taining products (although illnesses were later attrib
`uted to lipoid pneumonia from use to excipient vitamin
`E acetate).13 Because of marijuana’s Schedule I classif
`ication, researchers are prevented from conducting
`
`11 J. Marcu, Regulators Need to Rethink Restrictions on Cannabis
`Research. NATURE. 572, S19–S19 (2019) M.O. Bonn Miller, M.J.E.
`Loflin, B.F. Thomas, J.P. Marcu, et al., Labeling Accuracy of
`Cannabidiol Extracts Sold Online, JAMA, 318, 1708–1709 (2017).
`
`12 Id.
`
`13 C.G. Perrine, C.M. Pickens, T.K. Boehmer, B.A. King, et al.,
`Characteristics of a Multistate Outbreak of Lung Injury Associ
`ated with ECigarette Use, or Vaping—United States, 2019,
`MORBIDITY MORTAL WEEKLY REPORT, 68, 860–864 (2019).
`
`

`

`11
`
`representative studies and it is nearly impossible to
`study marijuana products and THC devices consumers
`use regardless of public health threat’s severity.14
`
`Because it would relieve the regulatory gridlock
`without simultaneously opening the floodgates for
`illicit uses under the disguise of “research”, a research
`exemption may be quick, yet calculated, solution for
`the existing obstacles researchers face. Descheduling
`marijuana and creating a research exemption would
`allow for researchers to efficiently and safely conduct
`studies that include a representative array of mari
`juana products. Beyond assisting in understanding
`marijuana from a health perspective, a research exemp
`tion will guide the rulemaking process regarding
`specific concerns (such as labeling, advertising, and
`packaging) and allow stakeholders, the FDA, and states
`to collaborate throughout the rulemaking process. This
`would track the Agricultural Improvement Act of 2018
`implementation in which the United States Congress
`granted the United States Department of Agriculture
`(“USDA”) with cultivation authority and the FDA
`authority over finished products containing hemp
`derived ingredients.
`
`As more states launch medical and adult use
`marijuana programs, promulgating uniform public
`health standards and rules to ensure public safety
`becomes increasing critical. Descheduling marijuana
`and carving out a defined legal pathway to enable
`the safe and efficient research to guide the creation
`
`14 C.M. Bowling, A.Y. Hafez, S.A. Glantz, Public Health and
`Medicine’s Need to Respond to Cannabis Commercialization in
`the United States A Commentary, JOURNAL OF PSYCHOACTIVE
`DRUGS, 1 6 (2020).
`
`

`

`12
`
`of the U.S.’s marijuana regulatory framework including
`increased FDA oversight of medical claims assessment
`and developing standard protocols for assessing drug
`efficacy and overall product safety. The FDA’s involve
`ment will also remedy a number of complications the
`domestic marijuana industry faces including a patch
`work of state specific marijuana products’ warning
`labels and universal THC symbols15 creating a univer
`sally recognized standard.
`
`Descheduling marijuana with federal and state
`regulatory oversight will mitigate public health risks
`and promote our knowledge. Without reliable data
`and replicable studies, it is impossible to regulate
`marijuana. Accordingly, it is necessary for the federal
`government to forge a legal pathway to encourage
`research to guide rulemaking that will allow Petition
`ers and Americans to access safe marijuana products.
`
`b. Advocates and Opponents Agree that Rescheduling
`will not resolve the Obstacles Researchers Face
`
`Advocates and opponents agree that rescheduling
`marijuana to another schedule will not resolve research,
`medicine, and overall product concerns. Marijuana
`opponents including Bertha Madras, Ph.D and Kevin
`Sabet, president of Smart Approaches to Marijuana
`(“SAM”) have spoken on this issue, with Dr. Madras
`publicly conceding that rescheduling marijuana as
`schedule II will not “open the floodgates for research”16
`
`15 A.J. Soroosh, R. Henderson, L. Dodson, C.S. Mitchell, J.W.
`Fahey, Mitigating Potential Public Health Problems Associated
`with Edible Cannabis Products Through Adequate Regulation
`a Landscape Analysis, CRITICAL REVIEWS IN FOOD SCIENCE AND
`NUTRITION, 1–9 (2020).
`
`16 Bertha Mardas, 5 Reasons Marijuana is Not Medicine, THE
`
`

`

`13
`
`and both Dr. Madras and Mr. Sabat stating that there
`is no benefit for public health.17
`
`NIDA director Nora Volkow acknowledged that
`marijuana’s legal status makes research “very dif
`ficult”18 and Mr. Sabet opined that marijuana’s federal
`status impedes studies and that moving cannabis to
`another schedule is not “desirable.”19
`
`Former supporter of Mr. Sabet and SAM, former
`Congressman Patrick Kennedy (D MA) recently
`suggested that descheduling marijuana may be “our
`best chance to actually dedicate resources toward
`consumer safety, abuse prevention, and treatment for
`those who need it.”20
`
`
`
`WASHINGTON POST, (April 29, 2016), https //www.washingtonpost.
`com/news/in theory/wp/2016/04/29/5 reasons marijuana is not
`medicine/.
`
`17 Chris Roberts, Prohibitionist Group Co Founder Backs
`Reclassifying Marijuana in Congressional Bid, MARIJUANA
`MOMENT, (January 26, 2020), https //www.marijuanamoment.
`net/wife of prohibitionist group co founder backs reclassifying
`marijuana in congressional bid/.
`
`18 Kyle Jaeger, Formerly AntiMarijuana Congressman Cosponsors
`Comprehensive Legalization Bill, MARIJUANA MOMENT, (January 9,
`2020), https //www.marijuanamoment.net/formerly anti marijuana
`congressman cosponsors comprehensive legalization bill/.
`
`19 Roberts, supra.
`
`20 Jaeger, supra.
`
`

`

`14
`
`
`
`CONCLUSION
`
`For the foregoing reasons, amici respectfully
`request that the Court grant the Petition for Writ of
`Certiorari.
`
`
`
`Respectfully submitted,
`
`DAVID KOTLER
` COUNSEL OF RECORD
`HOBAN LAW GROUP
`730 17TH STREET, SUITE 420
`DENVER, CO 80202
`(303) 674 7000
`DAVIDK@HOBAN.LAW
`
`COUNSEL FOR AMICI CURIAE
`
`SEPTEMBER 14, 2020
`
`

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