Cannabis Program Webinar Series - Paul Armentano of Deputy Director of NORML

1. Relevant Regulatory Issues
Pertaining to Cannabis
2016 Election Impact and Beyond
Cannavator.com
October 12, 2016
Paul Armentano
Deputy Director: NORML, NORML Foundation
Author: Marijuana Is Safer: So Why Are We Driving People to Drink?
Author: The Citizen’s Guide to State-By-State Marijuana Laws
Faculty: Oaksterdam University
Senior Policy Advisor: Freedom Leaf
Contributing Expert/Guest Columnist: Capitol Hill News Corp.

2. Existing Legal Landscape: States
• 26 states + WDC regulate medical cannabis use
– These programs are operational in all but four jurisdictions: LA, MD, PA
and OH
• 27 states have statutes specific to industrial hemp
– Most of these laws establish state-specific pilot programs that are
compliant with the 2014 Farm Act
• 16 states have statutes specific to CBD, but almost all of these
statutes are moot
– Exception: FL
• Four states + WDC regulate adult cannabis use
– District of Columbia does not permit market sales
– Washington state does not permit home cultivation

3. Existing Legal Landscape: Feds
• The cannabis plant (including all of its organic cannabinoids) is
a Schedule I controlled substance
– “high potential for abuse”
– “no currently accepted medical use in treatment”
– “lack of accepted safety for use … under medical supervision”
– Examples of schedule I substances: heroin, MDMA, LSD, cannabis
• Banking not permitted; businesses not recognized
• Only 4 percent of Congress support legalization:
http://norml.org/congressional-scorecard
– Partisan divide at the federal level: Dems far more likely to support
for: adult use, medical use, non-interference in state marijuana laws
than Repubs

4. Existing Legal Landscape: Feds
• Cole memorandum in effect (August 2013)
– https://www.justice.gov/iso/opa/resources/3052013829132756857467.p
df
– Directs US prosecutors not to interfere with state-specific regulatory
schemes pertaining to cannabis as long as those involved with such
programs are abiding by eight federal priorities (no diversion to other
states, do not engage in retail sales to minors, no use of federal lands, etc.)
• Rohrabacher-Farr amendment (2014)
– Federal funds cannot be used to prevent states from "implementing their
own state laws that authorize the use, distribution, possession or
cultivation of medical marijuana."
– Broad interpretation of the amendment upheld by Ninth Circuit Court of
Appeals (August 2016)
– Budgetary amendment, must be renewed annually

5. Presidential Candidates Positions
• Hilary Clinton
– Pledges to continue to abide by the Cole memorandum
– Pledges to reschedule cannabis from I to II
• Not clear how this change would be done: Rescheduling is
historically done via DEA but can also be addressed by Congress
– Privately has expressed support for banking reform
• Donald Trump
– Has also voiced support for non-interference in state marijuana laws
– Many of his advisor’s strongly opposed to cannabis law reform (e.g.,
Chris Christie, Michael Pence, Jess Sessions, etc.)

6. Election Day: Voters In Nine States
To Decide Cannabis Policy
• Adult use initiatives
– AZ, CA, MA, ME, NV
– Polling: CA: 60%-40%, MA: 53%-40%, ME: 53%-38%
• AZ, NV: polling virtually even
• Medical use initiatives
– AR, FL, MT, ND
– FL requires 60% support, polling has measures leader 77%-
18% (UNF poll)

7. Pending Federal Legislation
• Over two-dozen pieces of cannabis-specific legislation pending before
Congress
– Descheduling cannabis
– Rescheduling cannabis
– Rescheduling CBD
– Permitting banking
– Permitting VA docs to recommend cannabis
– Tax reform
– Hemp legalization
– Prioritizing research trials
• Lawmakers unlikely to hear/vote on any of these proposed measures

8. Pending Federal Amendments
• Rohrabacher-Farr amendment (2016)
– Language reapproved by majorities of the House/Senate
– Provisions included in October short-term appropriation extension
• Veterans Equal Access amendment (2016)
– Language approved by majorities of the House/Senate
– Provisions removed by House leadership in conference
• Banking amendment (2015)
– Language (Merkley/Murray amendment) approved in the Senate, not
voted on in the House; not included in final bill
– Reapproved in 2016 Senate, no vote in House

9. History of Rescheduling Petitions
• NORML files administrative petition in 1972
– Hearings before DEA do not take place until 1987/1988
– September 6, 1988: DEA ALJ rules: “[T]he marijuana plant … has a
currently accepted medical use in treatment in the United States.
There is no lack of accepted safety for use of it under medical
supervision. It it may lawfully be transferred from Schedule I to
Schedule II. … Refusal [to do so] would be unreasonable, arbitrary, and
capricious.”
– December 29, 1989: DEA administrator John Lawn sets aside the ruling
– February 18, 1994: US Court of Appeals for the District of Columbia
upholds the DEA’s actions

10. History of Rescheduling Petitions
• 1995: Petition filed by Jon Gettman/High Times Magazine
– DEA rejects this petition in 2001
• 2002: Petition filed by The Coalition for Rescheduling Cannabis
– May 2011: The Coalition files suit in federal court forcing DEA to respond to
the petition
– July 2011: DEA rejects the Coalition’s petition: "[T]here are no adequate and
well-controlled studies proving (marijuana's) efficacy; the drug is not accepted
by qualified experts. ... At this time, the known risks of marijuana use have not
been shown to be outweighed by specific benefits in well-controlled clinical
trials that scientifically evaluate safety and efficacy."
– July 2013: US Court of Appeals for the District of Columbia denies petitioners
request to order the DEA to reconsider their decision: “We will not disturb the
decision of an agency that has ‘examine[d] the relevant data and articulate[d]
a satisfactory explanation for its action.’”

11. History of Rescheduling Petitions
• 2009: petition filed by nurse practitioner Brian Krumm of New Mexico
• 2011: a second petition is filed by then-governors Christine Gregoire of
Washington and Lincoln Chafee of Rhode Island
• August 10, 2016: DEA rejects both petitions
– “[M]arijuana continues to be the most commonly used illicit drug, with
considerable rates of heavy abuse and dependence.”
– “There are not adequate safety studies on marijuana for use in any specific,
recognized medical condition. ... There are no adequate and well-controlled
studies that determine marijuana's efficacy. ... [T]here is no consensus of
opinion among experts concerning the medical utility of marijuana for use in
treating specific recognized disorders.”
– “[DEA is] unable to conclude that marijuana has an acceptable level of safety
in relation to its effectiveness in treating a specific and recognized disorder
due to lack of evidence with respect to a consistent and reproducible dose
that is contamination free.”

12. But, DEA For The First Time Calls
For ‘Pharmaceuticalization’
• DEA for the first time calls for an end to the U-Miss/NIDA
monopoly on providing research-grade cannabis for FDA-
approved clinical studies
– “The historical system, under which NIDA relied on one grower to supply
marijuana on a contract basis, was designed primarily to supply marijuana for
use in federally funded research – not for commercial product development.
Thus, under the historical system, there was no clear legal pathway for
commercial enterprises to produce marijuana for product development.”
– “In contrast, under the new approach, … persons may become registered with
DEA to grow marijuana not only to supply federally funded or other academic
researchers, but also for strictly commercial endeavors funded by the private
sector and aimed at drug product development.”

13. But, DEA For The First Time Calls
For ‘Pharmaceuticalization’
• DEA for the first time calls for an end to the U-Miss/NIDA
monopoly on providing research-grade cannabis for FDA-
approved clinical studies (cont)
– “In other words, in lieu of requiring the growers to operate under a
contract with NIDA, a registered grower will be permitted to operate
independently. … [U]nder the new approach, should the state of
scientific knowledge advance in the future such that a marijuana-
derived drug is shown to be safe and effective for medical use,
pharmaceutical firms will have a legal means of producing such drugs
in the United States – independent of the NIDA contract process.”

14. Is Scheduling An Impediment
For Research?
• Despite cannabis’ Schedule I status, a keyword search on
PubMed using the term “marijuana” yields over 24,207
scientific journal articles (as of 10/6/16) in the peer-reviewed
literature.
– A keyword search using the term “Tylenol” yields 19,841 citations
– A keyword search using the term “ibuprofen” yields 12,003 citations
– A keyword search using the term “Ritalin” yields 7,932 citations
– A keyword search using the term “hydrocodone” yields 886 citations
– A keyword search using the term “adderall” yields 190 citations

15. Is Scheduling An Impediment
For Research?
• Despite its Schedule I status, cannabis has been subject to far
more clinical trials than many FDA-approved medications
– JAMA: Clinical trial evidence supporting FDA approval of novel
therapeutic agents, 2005-2012, 2014.
• “Between 2005 and 2012, the FDA approved 188 novel
therapeutic agents for 206 indications on the basis of 488 pivotal
efficacy trials. The median number of pivotal trials per indication
was two although 74 indications (37%) were approved on the
basis of a single trial.”

16. What Would Rescheduling Do?
• Rescheduling cannabis would finally acknowledge the reality that
cannabis possess “accepted medical use in the United States”
• Rescheduling cannabis would likely permit banks and other financial
institutions to work with state-compliant cannabis business
• Rescheduling cannabis would likely permit state-compliant business
to take standard business deductions on the federal tax forms
• Rescheduling cannabis might open the door to changes in federal
workplace drug testing guidelines
• Rescheduling cannabis might lessen stigma among clinicians who
wish to facilitate clinical trials

17. What Rescheduling Won’t Do
• Rescheduling would not mandate medicinal cannabis be dispensed in
pharmacies
• Rescheduling would not amend federal regulations with regard to the
availability of cannabis for clinical research
• Rescheduling would not likely open the door for large-scale, long-term
Phase III trials
• Rescheduling would not provide legal protection from federal prosecution
to state-compliant marijuana operators
• Rescheduling would not likely result in any significant change in federal
prohibition
– Regulating cannabis like cocaine (Schedule II) rather than like heroin
(Schedule I) is hardly an improvement

18. Why NORML Favors Descheduling,
Not Rescheduling
• Reclassifying cannabis from I to II or to III continues to misrepresent the
plant’s safety relative to other controlled substances such as
methamphetamine (schedule II), anabolic steroids (schedule III), or alcohol
(unscheduled), and fails to provide states with the ability to regulate it
free from federal interference
• Rescheduling cannabis does little to significantly loosen the grasp of
federal prohibition or to make herbal cannabis readily accessible for
clinical study
• These goals can only be accomplished by federally descheduling cannabis
in a manner similar to alcohol and tobacco, thus providing states the
power to establish their own marijuana policies free from federal intrusion

19. About Me
• I am the Deputy Director NORML.
• My writing and research have appeared in over 750 publications, scholarly
and/or peer-reviewed journals, as well as in more than two dozen
textbooks and anthologies.
• I am the co-author of the book Marijuana is Safer: So Why Are We Driving
People to Drink? (2009/2013, Chelsea Green), which has been licensed
and translated internationally.
• I am also the author of The Citizens’ Guide to State-By-State Marijuana
Laws (2015, Whitman Press).
• I am the 2013 Freedom Law School Health Freedom Champion of the Year.
• I am the 2013 Alfred R. Lindesmith award recipient in the achievement in
the field of scholarship.

20. About Me
• I was the principle investigator for defense counsel in US v Schweder, the
first federal evidentiary hearing to determine the constitutionality of
cannabis as a schedule I controlled substance.
• I was a rebuttal expert in a successful Canadian constitutional challenge
(Crown v Allard) preserving qualified patients right to grow cannabis at
home.
• I serve on the faculty of Oaksterdam University, where he lectures on the
science in regard the the relative safety and therapeutic efficacy of
cannabis.
• I provide online content to TheAnswerPage.com, an online medical
educational resource that provides daily education to healthcare
professionals in 120 countries, as well as provides Continuing Medical
Education (CME) credit. This curriculum is now required in New York State
for any physician who wishes to participate in the state’s medical cannabis
program.
• Contact me at: paul@norml.org.