Cannabis rescheduling in the United States

Cannabis rescheduling in the United States is the proposed removal of marijuana from Schedule I of the Controlled Substances Act, the most tightly restricted category of drugs, by the U.S. Congress or the Attorney General. Since the early 1970s, cannabis reform advocates have been petitioning the U.S. Government to transfer marijuana to a different category that would allow medical use. Rescheduling proponents claim that cannabis is not addictive or harmful enough to meet the strict criteria for placement in Schedule I of the Controlled Substances Act. The Government argues that marijuana is, in fact, dangerous enough to merit Schedule I status, that marijuana does not meet its criteria for acceptable medical use, and that evidence of cannabis' widespread use is more relevant than animal studies in establishing the drug's abuse potential. The dispute is based on differing views of how the Act should be interpreted and what kinds of scientific evidence would be most relevant to the rescheduling decision.

The Controlled Substances Act provides a process for rescheduling controlled substances by petitioning the Drug Enforcement Administration. The first petition under this process was filed in 1972 to allow cannabis to be legally prescribed by physicians. The petition was ultimately denied after 22 years of court challenges, although a pill form of marijuana's psychoactive ingredient, THC, was rescheduled in 1985 to allow prescription under schedule II. In 1999 it was again rescheduled to allow prescription under schedule III. A second petition, based on claims related to clinical studies, was denied in 2001. The most recent rescheduling petition was filed by medical marijuana advocates in 2002.

Background
Schedule I Examples: Heroin, LSD, Marijuana, MDMA (Ecstasy), methaqualone (Quaalude).
 * The drug or other substance has a high potential for abuse.
 * The drug or other substance has no currently accepted medical use in treatment in the United States.
 * There is a lack of accepted safety for use of the drug or other substance under medical supervision.

Schedule II Examples: methadone, methamphetamine, methylphenidate (Ritalin), morphine, oxycodone (OxyContin), phencyclidine (PCP).
 * The drug or other substance has a high potential for abuse.
 * The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.
 * Abuse of the drug or other substances may lead to severe psychological or physical dependence.

Schedule III Examples: Anabolic steroids, ketamine (Special K), synthetic THC (Marinol). Schedule IV Examples: Alprazolam (Xanax), diazepam (Valium). Schedule V Examples: Certain codeine preparations; certain opium preparations.
 * The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II.
 * The drug or other substance has a currently accepted medical use in treatment in the United States.
 * Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
 * The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule III.
 * The drug or other substance has a currently accepted medical use in treatment in the United States.
 * Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III.
 * The drug or other substance has a low potential for abuse relative to the drugs or other substances in schedule IV.
 * The drug or other substance has a currently accepted medical use in treatment in the United States.
 * Abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule IV.

Schedule I is the only category of controlled substances that may not be prescribed by a physician. Under , drugs must meet three criteria in order to be placed in Schedule I:
 * The drug or other substance has a high potential for abuse.
 * The drug or other substance has no currently accepted medical use in treatment in the United States.
 * There is a lack of accepted safety for use of the drug or other substance under medical supervision.

In 1970, Congress placed marijuana into Schedule I on the advice of Assistant Secretary of Health Roger O. Egeberg. His letter to Harley O. Staggers, Chairman of the House Committee on Interstate and Foreign Commerce, indicates that the classification was intended to be provisional:


 * Dear Mr. Chairman: In a prior communication, comments requested by your committee on the scientific aspects of the drug classification scheme incorporated in H.R. 18583 were provided. This communication is concerned with the proposed classification of marijuana.


 * It is presently classed in schedule I(C) along with its active constituents, the tetrahydrocannibinols and other psychotropic drugs.


 * Some question has been raised whether the use of the plant itself produces "severe psychological or physical dependence" as required by a schedule I or even schedule II criterion. Since there is still a considerable void in our knowledge of the plant and effects of the active drug contained in it, our recommendation is that marijuana be retained within schedule I at least until the completion of certain studies now underway to resolve the issue. If those studies make it appropriate for the Attorney General to change the placement of marijuana to a different schedule, he may do so in accordance with the authority provided under section 201 of the bill. . .


 * Sincerely yours, (signed) Roger O. Egeberg, M.D.

The reference to "certain studies" is to the then-forthcoming National Commission on Marijuana and Drug Abuse. In 1972, the Commission released a report favoring decriminalization of marijuana. The Richard Nixon administration took no action to implement the recommendation, however. A protracted struggle ensued in which marijuana reform activists began working through all three branches of government to reschedule the drug.

For rescheduling
Former director of the National Organization for the Reform of Marijuana Laws Jon Gettman has argued that marijuana does not fit each of the three statutory criteria for Schedule I. Gettman believes that "high potential for abuse" means that a drug has a potential for abuse similar to that of heroin or cocaine. Gettman argues further that since laboratory animals do not self-administer marijuana, and because marijuana's toxicity is less than that of heroin or cocaine, marijuana lacks the high abuse potential required for inclusion in Schedule I or II.

Gettman also contends: "The acceptance of cannabis' medical use by eight [now thirteen] states since 1996 and the experiences of patients, doctors, and state officials in these states establish marijuana's accepted medical use in the United States." Specifically, Alaska, California, Colorado, Hawaii, Maine, Maryland, Montana, Nevada, New Mexico, Oregon, Rhode Island, Vermont, and Washington have enacted legislation allowing the medical use of marijuana by their citizens. A minimum of 35,000 patients are currently using medical marijuana legally in these states, and over 2,500 different physicians have recommended it for use by their patients.

In his petition, Gettman also argues that marijuana is an acceptably safe medication. He notes that a 1999 Institute of Medicine report found that "except for the harms associated with smoking, the adverse effects of marijuana use are within the range of effects tolerated for other medications." He points out that there are a number of delivery routes that were not considered by the Institute, such as transdermal, sublingual, and even rectal administration, in addition to vaporizers, which release marijuana's active ingredients into the air without burning the plant matter.

A study published in the March 1 1990 issue of the Proceedings of the National Academy of Sciences stated that "there are virtually no reports of fatal cannabis overdose in humans" and attributed this safety to the low density of cannabinoid receptors in areas of the brain controlling breathing and the heart. Gettman claims that the discovery of the cannabinoid receptor system in the late 1980s revolutionized scientific understanding of cannabis' effects and provided further evidence that it does not belong in Schedule I.

Against rescheduling
In 1992, DEA Administrator Robert Bonner promulgated five criteria, based somewhat on the Controlled Substances Act's legislative history, for determining whether a drug has an accepted medical use. The DEA claims that marijuana has no accepted medical use because it does not meet all of these criteria:
 * The drug's chemistry is known and reproducible;
 * There are adequate safety studies;
 * There are adequate and well-controlled studies proving efficacy;
 * The drug is accepted by qualified experts; and
 * The scientific evidence is widely available.

Marijuana is one of several hallucinogens with unproven abuse potential and toxicity that Congress placed in Schedule I. The DEA interprets the Controlled Substances Act to mean that if a drug with even a low potential for abuse — say, equivalent to a Schedule V drug — has no accepted medical use, then it must remain in Schedule I: When it comes to a drug that is currently listed in schedule I, if it is undisputed that such drug has no currently accepted medical use in treatment in the United States and a lack of accepted safety for use under medical supervision, and it is further undisputed that the drug has at least some potential for abuse sufficient to warrant control under the CSA, the drug must remain in schedule I. In such circumstances, placement of the drug in schedules II through V would conflict with the CSA since such drug would not meet the criterion of "a currently accepted medical use in treatment in the United States." 21 USC 812(b). Therefore, even if one were to assume, theoretically, that your assertions about marijuana's potential for abuse were correct (i.e., that marijuana had some potential for abuse but less than the "high potential for abuse" commensurate with schedules I and II), marijuana would not meet the criteria for placement in schedules III through V since it has no currently accepted medical use in treatment in the United States—a determination that is reaffirmed by HHS in the attached medical and scientific evaluation.

The Department of Health and Human Services rejects the argument that laboratory animals' failure to self-administer marijuana is conclusive proof of its low potential for abuse: The Secretary disagrees with Mr. Gettman's assertion that "[t]he accepted contemporary legal convention for evaluating the abuse potential of a drug or substance is the relative degree of self-administration the drug induces in animal subjects." As discussed above, self-administration tests that identify whether a substance is reinforcing in animals are but one component of the scientific assessment of the abuse potential of a substance. Positive indicators of human abuse liability for a particular substance, whether from laboratory studies or epidemiological data, are given greater weight than animal studies suggesting the same compound has no abuse potential.

The Food and Drug Administration elaborates on this, arguing that the widespread use of marijuana, and the existence of some heavy users, is evidence of its "high potential for abuse," despite the drug's lack of physiological addictiveness: [P]hysical dependence and toxicity are not the only factors to consider in determining a substance's abuse potential. The large number of individuals using marijuana on a regular basis and the vast amount of marijuana that is available for illicit use are indicative of widespread use. In addition, there is evidence that marijuana use can result in psychological dependence in a certain proportion of the population.

The Government also considers the fact that people are willing to risk scholastic, career and legal problems to use marijuana to be evidence of its high potential for abuse: Throughout his petition, Mr. Gettman argues that while many people "use" marijuana, few "abuse" it. He appears to equate abuse with the level of physical dependence and toxicity resulting from marijuana use. Thus, he appears to be arguing that a substance that causes only low levels of physical dependence and toxicity must be considered to have a low potential for abuse. The Secretary does not agree with this argument. Physical dependence and toxicity are not the only factors that are considered in determining a substance's abuse potential. The actual use and frequency of use of a substance, especially when that use may result in harmful consequences such as failure to fulfill major obligations at work or school, physical risk-taking, or even substance-related legal problems, are indicative of a substance's abuse potential.

Process
Marijuana could be rescheduled either legislatively, through Congress, or through the executive branch. Congress has so far rejected all bills to reschedule marijuana. However, it is not unheard of for Congress to intervene in the drug scheduling process; in February 2000, for instance, Congress passed Public Law 106-172, also known as the Hillory J. Farias and Samantha Reed Date-Rape Drug Prohibition Act of 2000, adding GHB to Schedule I.

The Controlled Substances Act also provides for a rulemaking process by which the United States Attorney General can reschedule marijuana administratively. These proceedings represent the only means of legalizing medical marijuana without an act of Congress. Rescheduling supporters have often cited the lengthy petition review process as a reason why marijuana is still illegal. The first petition took 22 years to review, and the second took 7 years. In 2002, the Coalition for Rescheduling Cannabis filed a third petition.

Rulemaking proceedings

 * Filing of Petition with DEA
 * Acceptance of Petition by DEA
 * Initial Review by DEA
 * Referral to HHS
 * Scientific and Medical Evaluation by HHS
 * HHS Report to DEA
 * Evaluation of Additional Information by DEA
 * Publication of DEA Decision
 * (Judicial review by the U.S. Court of Appeals)
 * (Public Hearing on Disputed Matters of Fact)

The United States Code, under Section 811 of Title 21, sets out a process by which cannabis could be administratively transferred to a less-restrictive category or removed from Controlled Substances Act regulation altogether. The Drug Enforcement Administration (DEA) evaluates petitions to reschedule marijuana. However, the Controlled Substances Act gives the Department of Health and Human Services (HHS), as successor agency of the Department of Health, Education, and Welfare, great power over rescheduling decisions.

After the DEA accepts the filing of a petition, the agency must request from the HHS Secretary "a scientific and medical evaluation, and his recommendations, as to whether such drug or other substance should be so controlled or removed as a controlled substance." The Secretary's findings on scientific and medical issues are binding on the DEA. The HHS Secretary can even unilaterally legalize marijuana: "[I]f the Secretary recommends that a drug or other substance not be controlled, the Attorney General shall not control the drug or other substance." .

Factors
Unless an international treaty requires controlling a substance, the Attorney General must, in finding whether the drug meets the three criteria for placement in a particular schedule, consider the following factors:
 * The drug's actual or relative potential for abuse.
 * Scientific evidence of its pharmacological effect, if known.
 * The state of current scientific knowledge regarding the drug or other substance.
 * Its history and current pattern of abuse.
 * The scope, duration, and significance of abuse.
 * What, if any, risk there is to the public health.
 * Its psychological or physiological dependence liability.
 * Whether the substance is an immediate precursor of a controlled substance.

International treaty


If an international treaty, ratified by the U.S., mandates that a drug be controlled, the Attorney General is required to "issue an order controlling such drug under the schedule he deems most appropriate to carry out such obligations" without regard to scientific or medical findings. Under the Single Convention on Narcotic Drugs, cannabis and cannabis resin are classified under Schedule IV, that treaty's most strictly controlled category of drugs. However, Article 4(c) of the Single Convention specifically excludes medicinal drug use from prohibition, requiring only that Parties "limit exclusively to medical and scientific purposes the production, manufacture, export, import, distribution of, trade in, use and possession of drugs". On the other hand, Article 2(5)(b) states that for Schedule IV drugs:
 * A Party shall, if in its opinion the prevailing conditions in its country render it the most appropriate means of protecting the public health and welfare, prohibit the production, manufacture, export and import of, trade in, possession or use of any such drug except for amounts which may be necessary for medical and scientific research only, including clinical trials therewith to be conducted under or subject to the direct supervision and control of the Party.

The clause "...in its opinion..." refers to a judgment that each nation makes for itself. The official Commentary on the treaty indicates that Parties are required to make the judgment in good faith. Thus, if in the opinion of the United States, limiting cannabis use solely to research purposes would be "the most appropriate means of protecting the public health and welfare," the U.S. would be required to do that. Presumably, this would greatly restrict the possibilities for medical use.

Jon Gettman, in Science and the End of Marijuana Prohibition, claims that "if prohibition ends in the U.S. it must also end world-wide because U.S. law requires that we amend international drug control treaties to correspond with our own findings on scientific and medical issues". This is at least partially correct; 21 U.S.C. § 811(d)(2)(B) of the Controlled Substances Act states that if the United Nations Commission on Narcotic Drugs proposes rescheduling a drug, the HHS Secretary "shall evaluate the proposal and furnish a recommendation to the Secretary of State which shall be binding on the representative of the United States in discussions and negotiations relating to the proposal". As the major financial contributor to the United Nations Office on Drugs and Crime and related agencies, the U.S. has a great deal of influence over international drug policy. However, former United Nations Drug Control Programme Chief of Demand Reduction Cindy Fazey points out in The UN Drug Policies and the Prospect for Change that since cannabis restrictions are embedded in the text of the Single Convention, complete legalization would require denunciation of the Single Convention, amendment of the treaty, or a reinterpretation of its provisions that would likely be opposed by the International Narcotics Control Board.

1972 NORML petition
On May 18 1972, the National Organization for the Reform of Marijuana Laws (NORML) petitioned the Bureau of Narcotics and Dangerous Drugs (BNDD) (now the Drug Enforcement Administration (DEA)) to transfer marijuana to Schedule II so that it could be legally prescribed by physicians. The BNDD declined to initiate proceedings on the basis of their interpretation of U.S. treaty commitments.

In 1974, the United States Court of Appeals for the District of Columbia Circuit ruled against the government and ordered them to process the petition (NORML v. Ingersoll 497 F.2d 654). The government continued to rely on treaty commitments in their interpretation of scheduling-related issues concerning the NORML petition. In 1977, the Court issued a decision clarifying that the Controlled Substances Act requires a full scientific and medical evaluation and the fulfillment of the rescheduling process before treaty commitments can be evaluated (NORML v. DEA 559 F.2d 735). On October 16 1980, the Court ordered the government to start the scientific and medical evaluations required by the NORML petition (NORML v. DEA Unpublished Disposition, U.S. App. LEXIS 13100).

Meanwhile, some members of Congress were taking action to reschedule the drug legislatively. In 1981, the late Rep. Stuart McKinney introduced a bill to transfer marijuana to Schedule II. It was co-sponsored by a bipartisan coalition of 84 House members, including prominent Republicans Newt Gingrich (GA), Bill McCollum (FL), John Porter (IL), and Frank Wolf (VA). After the bill died in committee, Rep. Barney Frank began annually introducing nearly identical legislation. All of Frank's bills have suffered the same fate, though, without attracting more than a handful of co-sponsors.

On October 18, 1985, the DEA issued a Notice of Proposed Rulemaking to transfer "Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules" — a pill form of Δ9-tetrahydrocannabinol, the main psychoactive component of marijuana, sold under the brand name Marinol — from Schedule I to Schedule II (DEA 50 FR 42186-87). The government issued its final rule rescheduling the drug on July 13 1986 (DEA 51 FR 17476-78). The disparate treatment of marijuana and the expensive, patentable Marinol prompted reformers to question the DEA's consistency.

Parties supporting rescheduling Parties opposing rescheduling
 * NORML, a membership-funded educational organization, founded in 1970, which opposes all criminal prohibitions against marijuana and marijuana smoking.
 * The Alliance for Cannabis Therapeutics, a nonprofit organization founded in 1980 to make marijuana available by prescription.
 * The Cannabis Corporation of America, a pharmaceutical firm established with the intention of extracting natural cannabinoids for therapeutic use when cannabis is placed in Schedule II.
 * The Ethiopian Zion Coptic Church, which considers marijuana a sacred plant essential to its religious rituals.
 * The Drug Enforcement Administration.
 * The International Association of Chiefs of Police.
 * The National Federation of Parents for Drug-Free Youth, a membership-funded educational organization.

In the summer of 1986, the DEA administrator initiated public hearings on cannabis rescheduling. The hearings lasted two years, involving many witnesses and thousands of pages of documentation. On September 6, 1988, DEA Chief Administrative Law Judge Francis L. Young ruled that marijuana did not meet the legal criteria of a Schedule I prohibited drug and should be reclassified. He declared that marijuana in its natural form is "one of the safest therapeutically active substances known to man. (T)he provisions of the (Controlled Substances) Act permit and require the transfer of marijuana from Schedule I to Schedule II".

Then-DEA Administrator John Lawn overruled Young's determination. Lawn said he decided against re-scheduling marijuana based on testimony and comments from numerous medical doctors who had conducted detailed research and were widely considered experts in their respective fields. Later Administrators agreed. "Those who insist that marijuana has medical uses would serve society better by promoting or sponsoring more legitimate research," former DEA Administrator Robert Bonner opined in 1992. This statement was quoted by the Multidisciplinary Association for Psychedelic Studies (MAPS) in its membership drives.

In 1994, the D.C. Court of Appeals finally affirmed the DEA Administrator's power to overrule Judge Young's decision (Alliance for Cannabis Therapeutics v. DEA. 15 F.3d 1131). The petition was officially dead. "Each of the doctors testifying on behalf of NORML claimed that his opinion was based on scientific studies, yet with one exception, none could identify, under oath, the scientific studies they relied on," DEA Administrator Thomas A. Constantine remarked in 1995.

1995 Gettman and High Times petition
On July 10 1995, Jon Gettman and High Times Magazine filed another rescheduling petition with the DEA. This time, instead of focusing on marijuana's medical uses, the petitioners claimed that marijuana did not have the "high potential for abuse" required for Schedule I or Schedule II status. They based their claims on studies of the brain's cannabinoid receptor system conducted by the National Institute of Mental Health (NIMH) between 1988 and 1994. In particular, they claim that a 1992 study by M. Herkenham et al, "using a lesion-technique, established that there are no cannabinoid receptors in the dopamine-producing areas of the brain". Other studies, summarized in Gettman's 1997 report Dopamine and the Dependence Liability of Marijuana, showed that marijuana has only an indirect effect on dopamine transmission. This suggested that marijuana's psychoactive effects are produced by a different mechanism than addictive drugs such as amphetamine, cocaine, ethanol, nicotine, and opiates. The National Institute on Drug Abuse, however, continued to publish literature contradicting this finding. For instance, NIDA claims the following in its youth publication The Science Behind Drug Abuse:
 * A chemical in marijuana, THC, triggers brain cells to release the chemical dopamine. Dopamine creates good feelings — for a short time. Here's the thing: Once dopamine starts flowing, a user feels the urge to smoke marijuana again, and then again, and then again. Repeated use could lead to addiction, and addiction is a brain disease.

In January 1997, the White House Office of National Drug Control Policy (ONDCP) asked the Institute of Medicine (IOM) to conduct a review of the scientific evidence to assess the potential health benefits and risks of marijuana and its constituent cannabinoids. In 1999, the IOM recommended that medical marijuana use be allowed for certain patients in the short term, and that preparations of isolated cannabinoids be developed as a safer alternative to smoked marijuana. The IOM also found that the gateway drug theory was "beyond the issues normally considered for medical uses of drugs and should not be a factor in evaluating the therapeutic potential of marijuana or cannabinoids."

Both sides claimed that the IOM report supported their position. The DEA publication Exposing the Myth of Smoked Medical Marijuana interpreted the IOM's statement, "While we see a future in the development of chemically defined cannabinoid drugs, we see little future in smoked marijuana as a medicine," as meaning that smoking marijuana is not recommended for the treatment of any disease condition. Marijuana advocates pointed out that the IOM did not study vaporizers, devices which, by heating cannabis to 185°C, release therapeutic cannabinoids while reducing or eliminating ingestion of various carcinogens.

On July 2 1999, Marinol was again rescheduled, this time from Schedule II to the even less-restrictive Schedule III, while marijuana remained in Schedule I (64 FR 35928). The petitioners argued that the distinction between the two drugs was arbitrary, and that marijuana should be rescheduled as well. The DEA, however, continued to support Marinol as a method of THC ingestion without harmful smoke inhalation.

The DEA published a final denial of Gettman's petition on April 18, 2001 (DEA 66 FR 20037 – 20076). The U.S. Court of Appeals for the D.C. Circuit upheld the agency's decision on May 24, 2002, ruling that the petitioners were not sufficiently injured to have standing to challenge DEA's determinations in federal court (290 F.3d 430). Since the appeal was dismissed on a technicality, it is unknown what position the Court would have taken on the merits of the case.

2002 Coalition for Rescheduling Cannabis petition
On October 9 2002, the Coalition for Rescheduling Cannabis filed another petition. The new organization consisted of medical marijuana patients and other petitioners who would be more directly affected by the DEA's decision. On April 3 2003, the DEA accepted the filing of that petition. According to Jon Gettman, "In accepting the petition the DEA has acknowledged that the Coalition has established a legally significant argument in support of the recognition of the accepted medical use of cannabis in the United States."

Gettman speculates that if marijuana is removed from Schedule I, three possible outcomes are that marijuana could be:
 * Regulated as a Schedule III or IV prescription drug, similarly to ketamine or anabolic steroids;
 * Regulated as a Schedule V over-the-counter substance; or
 * Removed from the Schedules and regulated similarly to alcoholic beverages or tobacco.

In a footnote to the majority decision in Gonzales v. Raich, Justice John Paul Stevens said that if the scientific evidence offered by medical marijuana supporters is true, it would "cast serious doubt" on the Schedule I classification.