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, if known.
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 system.
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.