This petition is based on consideration of research findings
not examined in prior proceedings, the emergence of new research
findings about marijuana/cannabis since prior rescheduling
proceedings, and research findings that cast the record of
prior proceedings in a new light.
The Controlled Substances Act specifies eight factors that
determine control of a drug or substance or its removal from
schedules. The CSA states that these eight factors will be
considered when making any finding regarding a drug's accepted
medical use, safety for use, abuse potential, or dependence
liability; all eight of these factors must be considered in
determining the scheduling or rescheduling of cannabis. (21
USC 811(c)) A review of the scientific and medical record
for these factors supports recognition of the accepted medical
use of cannabis in the United States and requires its rescheduling
under the CSA.
(1) Its actual or relative potential for abuse.
The scientific record indicates that cannabis does not have
a high potential for abuse; a majority of users do not experience
problems which characterize drug abuse. Indications of abuse
of cannabis occur at lower rates than for other scheduled
drugs such as cocaine and heroin. Neither the actual nor relative
potential for abuse of cannabis is sufficiently high to render
cannabis unsafe for medical use.
(2) Scientific evidence of its pharmacological effect,
The pharmacological effects of cannabinoid drugs are well-established
through both basic and clinical research and are widely documented
in the scientific record. The pharmacological effects of cannabis
are sufficiently well-known by the scientific and medical
communities to have resulted in the accepted medical use of
cannabis by doctors and health care professionals.
(3) The state of current scientific knowledge regarding
the drug or other substance.
Contemporary scientific knowledge has confirmed the accuracy
of patient accounts of the therapeutic effects of cannabis.
The side effects of acute use are also well-known and the
safety of long-term medical use has also been established.
(4) Its history and current pattern of abuse.
The use and abuse of cannabis has been widespread in the
United States since national drug use surveys began in the
1970s. A considerable number of cannabis users suffer from
problems that meet the criteria for abuse. However, the large
majority of cannabis users do not experience any relevant
problems related to their use.
(5) The scope, duration, and significance of abuse.
When compared to legal drugs, abuse problems with cannabis
are generally less severe.
6) What, if any, risk there is to the public health.
There is no demonstrable risk to public health posed by medical
cannabis use. The denial of therapeutic access to cannabis
creates a far greater risk to public health than the minor
acute effects of the drug and/or its long-term use under medical
use under medical supervision.
(7) Its psychic or physiological dependence liability.
There is a general consensus in the scientific community
that cannabis has a relatively low dependence liability compared
to other scheduled drugs and substances.
(8) Whether the substance is an immediate precursor
of a substance already controlled under this subchapter.
Cannabis is a natural source of dronabinol (THC), the ingredient
of Marinol™, a Schedule III drug. There are no grounds
to schedule cannabis in a more restrictive schedule than Marinol™.
There have been two prior cannabis rescheduling petitions
that have resulted in formal review under the provisions of
the Controlled Substances Act. The first of these was filed
by NORML in 1972, was subject to numerous court battles, and
was finally resolved in 1994. (Alliance for Cannabis Therapeutics
v. Drug Enforcement Administration, 15 F.3d 1131 (D.C. Cir.
1994)) By the time it was the subject of administrative hearings
and final judicial review the NORML petition solely concerned
marijuana's accepted medical use and safety for use under
medical supervision. The second petition was filed by Jon
Gettman and High Times in 1995, and was formally rejected
by the Drug Enforcement Administration in 2001. Judicial review
was denied by the Court of Appeals because the petitoners
had insufficient standing to involve the federal courts. (Jon
Gettman and High Times Magazine v. Drug Enforcement Administration,
D.C. Cir. 2001. No. 01-1182,decided March 24, 2002.) The Gettman
petition argued that marijuana did not have the high potential
for abuse required for Schedule I or Schedule II status.
In their review of the Gettman petition neither DEA nor HHS
gave any consideration to marijuana's medical use, its safety
for use, its relative abuse potential or its relative dependence
liability, as called for by the Controlled Substances Act
(CSA). This petition addresses all of these relevant issues.
This petition is being filed by a coalition of interested
parties including non-profit organizations and individual
citizens. The membership of these organizations and these
individual citizens have various interests in the appropriate
scheduling of cannabis under federal law, including but not
limited to an interest in legal access to cannabis for therapeutic
use based on existing medical conditions.
In the following, the terms "marijuana" and "cannabis"
will be used synonymously. The latter is often preferred in
the scientific community with regard to medicinal uses of
the plant Cannabis sativa L. and its derivatives.
Key developments in the assessment of marijuana's medical
use include: acceptance of marijuana's medical use by health
care professionals; recognition of marijuana as a medicine
of last resort by the Institute of Medicine of the National
Academy of Sciences; recognition of the therapeutic properties
of cannabinoids by the scientific community and health care
providers; the emergence of basic research explaining the
mode of action of cannabis-based medicines; the emergence
of clinical research on the medical use of cannabis; and acceptance
of marijuana's medical use by eight states. These developments
contradict the CSA's classification of marijuana as having
no accepted medical use in the United States.
There is also a growing consensus among scientists and health
care providers that in lieu of alternatives marijuana is an
adequate delivery system for cannabinoid drugs, and more specifically
a consensus that data on the medical efficacy of THC and other
cannabinoids drugs is sufficient to recognize marijuana's
accepted medical use in the United States.
Because of the nature of the statute "accepted medical
use in the United States" exists in society prior to
recognition by DEA by way of the fact finding process outlined
in 21 USC 811(c), which establishes factors determinative
of control. Marijuana does not have to be the best medicine
for various conditions, nor does it have to be the best delivery
form for cannabinoid drugs, in order to have an accepted medical
use. All drugs have side-effects and most conditions have
alternate therapies. These are criteria relevant to the drug
approval process under the Federal Food Drug and Cosmetic
Act (FFDCA), however the CSA's different regulatory purpose
provides for simple consideration as to whether or not there
is a legitimate need for a regulatory regimen under the CSA.
Nor does recognition of accepted medical use under the CSA
imply that a substance is recommended for use, this is not
even implied by FDA approval.
Marijuana's low dependence liability and low toxicity compared
to other drugs of abuse are inconsistent with the drug having
the high potential for abuse implied by Schedule I of the
CSA. Many individuals use marijuana recreationally or medicinally
without becoming dependent or otherwise developing drug abuse
problems. Recent evidence shows that far fewer regular users
of marijuana have dependency problems than of other drugs
such as nicotine or cocaine. Recent evidence indicates that
marijuana has an effect on dopamine production in the brain,
which is somewhat similar to other legal and illegal drugs
(nicotine, caffeine, cocaine, heroin, etc.) and that animals
self-administer cannabinoid-1-receptor agonists under certain
conditions. However, the actual abuse potential and dependence
liability in humans cannot be derived from this basic research,
which only helps to explain observations of human behavior.
Marijuana's relative abuse potential has never been assessed
as part of rescheduling proceedings. Rather than considering
relative toxicity, physical dependence, and pharmacological
or neurotoxic effects, in their review of the 1995 petition
to reschedule marijuana, the DEA relied, instead, upon social
survey data regarding the relative number of users, emergency
room visits, and drug treatment admissions for marijuana versus
cocaine and heroin. Such crude measures of abuse cannot substitute
for the scientific evaluations required by the CSA and performed
by the DEA for MDMA, butorphanol and other controlled substances.
Along with assessments of marijuana's low dependence liability
and low potential for abuse, recent research findings give
new credence to the claims of patients that marijuana has
therapeutic value for them. This scientific evidence casts
testimony in original NORML marijuana rescheduling proceedings
in a new light.
The legislative history of the Controlled Substances Act
requires that the impact of proposed regulations on those
most affected by them should be considered as part of the
rescheduling process. Two impacts must be considered. With
respect to the research, manufacture, and distribution related
to marijuana's possible sale as a medicinal drug in accordance
with U.S. FDA regulations, the rescheduling of marijuana would
lower the development costs associated with securing FDA approval.
Second, the impact of rescheduling on individuals who require
marijuana for medical purposes must be considered with respect
to assessing marijuana's accepted medical use and safety.
Continued prohibition of marijuana's medicinal use has a costly
effect on individuals who require it for therapeutic use;
rescheduling would expedite its legal availability to these
individuals both with respect to entry into suitable research
programs and to development of a legal production and delivery
When considering the criteria specified by the CSA for making
findings determinative of scheduling, it is apparent in light
of the above that marijuana has at most a similar potential
for abuse and dependence liability to Schedule III substances
with accepted medical uses in the United States, such as dronabinol
(THC) and codeine. This is particularly true in comparison
with dronabinol (Marinol™), as it has recently been
demonstrated that the medicinal effects of dronabinol and
marijuana are largely identical. Consequently, this petition
requests proceedings to have marijuana removed from Schedule
I and rescheduled in either of Schedules III, IV or V of the
Controlled Substances Act based on a formal assessment of
its relative abuse potential and dependence liability.
The reclassification of cannabis under state and national
law is a well-established trend based on an ongoing recognition
by government's, legislative bodies, and electorates that
the scientific record does not justify prohibition of cannabis
or its classification in the same legal category as narcotic
and other dangerous drugs. For example the governments of
Canada and Great Britain have recently recognized the need
to change the legal status of cannabis in order to facilitate
medical access. Furthermore, differences with the U.S. regulatory
position have already been established in most U.S. states.
Rescheduling of cannabis to distinguish it under the law from
more dangerous drugs is wide-spread at the state level (see
summary below). Only 6 states have scheduled marijuana in
conformity with its federal Schedule I status. Marijuana has
its own distinct schedule in 39 states while 5 others have
placed it in either a Schedule V or Schedule VI.
For all of these reasons the scientific record provides a
compelling case for the removal of mariuana from Schedule
I and the rescheduling of cannabis in Schedule III or a less
restrictive schedule. This rescheduling would not only exedite
the availability of legal cannabis to patients in need, but
it would also bring the goverment into compliance with the
Controlled Substances Act which, subject to appropriate regulatory
restrictions, mandates public access to therapeutic drugs
and substances, including cannabis.