Schedules of Controlled Substances
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.
Examples: LSD, MDMA, heroin, methamphetamine, marijuana.
Schedule II
- 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.
Examples: Cocaine, morphine, hydrocodone.
Schedule III
- 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.
Examples: Ketamine, anabolic steroids, synthetic THC (Marinol).
Schedule IV
- 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.
Examples: Alprazolam (Xanax), diazepam (Valium).
Schedule V
- 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.
Examples: Certain opium preparations; certain codeine preparations.
Cannabis rescheduling refers to the removal of marijuana from Schedule I, the most tightly-restricted category of drugs, by the United States Congress or the United States Attorney General. Jon Gettman and other marijuana reform activists advocate transferring marijuana to a different category in order to allow medical use. They argue that its current status is illegal under federal law, contending that recent scientific evidence shows it does not meet the Controlled Substances Act's strict criteria for placement in Schedule I.
Background
Schedule I is the only category of controlled substances that may not be prescribed by a physician. Under 21 USC Sec. 812, drugs must meet three criteria in order to be placed in Schedule I[1] (http://www.usdoj.gov/dea/pubs/csa/812.htm#b):
- The drug or other substance has a high potential for abuse.
- The drug or other substances 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. Egeberg, citing the "considerable void" in scientific knowledge about the drug, recommended that it be retained in that category pending the report of the National Commission on Marihuana and Drug Abuse. He noted that the executive branch could later reschedule marijuana without legislative action "if those studies make it appropriate".
In 1972, the Commission released a report favoring legalization 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.
Legislative initiatives
In 1981, the late Rep. Stuart McKinney introduced a a bill to transfer marijuana to Schedule II[2] (http://www.marijuananews.com/congressional_record_on_the_hous.htm). It was co-sponsored by a bipartisan coalition of 84 House members, including prominent Republicans Newt Gingrich (Ga.), Bill McCollum (Fla.), John Porter (Ill.), and Frank Wolf (Va.)[3] (http://www.mpp.org/releases/nr111395.html). The bill died in committee.
Since the early 1980s, Rep. Barney Frank has annually introduced legislation nearly identical to the 1981 bill[4] (http://www.safeaccessnow.org/article.php?id=679). All of Frank's bills have died in committee without attracting more than a handful of co-sponsors. Despite the failure of these measures, it is not unheard of for Congress to intervene in the scheduling process; for instance, Congress added GHB to Schedule I in March 2000[5] (http://www.whitehousedrugpolicy.gov/publications/factsht/gamma/).
Administrative initiatives
The Controlled Substances Act provides for a rulemaking process by which the United States Attorney General can reschedule marijuana administratively. These proceedings, usually initiated by a petition from marijuana reform advocates, 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[6] (http://www.marijuananews.com/marijuananews/cowan/science_and_the_end_of_marijuana.htm). 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 process
21 USC Sec. 811 sets out a process by which cannabis could be transferred to a less-restrictive category or removed from Controlled Substances Act regulation altogether[7] (http://www.usdoj.gov/dea/pubs/csa/811.htm). The Drug Enforcement Administration (DEA) evaluates petitions to reschedule marijuana. However, the Controlled Substances Act gives the United States Department of Health and Human Services (DHHS), as successor agency of the United States Department of Health, Education, and Welfare, great power over rescheduling decisions.
Rescheduling proceedings consist of these stages:
- Filing of Petition with DEA
- Acceptance of Petition by DEA
- Initial Review by DEA
- Referral to DHHS
- Scientific and Medical Evaluation by DHHS
- HHS Report to DEA
- Evaluation of Additional Information by DEA
- Publication of DEA Decision
- (Judicial Review by the US Court of Appeals)
- (Public Hearing on Disputed Matters of Fact)
After the DEA accepts the filing of a petition, the agency must request from the DHHS 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 DHHS 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."
Unless an international treaty requires controlling a substance, the Attorney General must base his decision on these factors with respect to the drug or other substance:
- Its 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 psychic or physiological dependence liability.
- Whether the substance is an immediate precursor of a controlled substance.
International considerations
If an international treaty 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. However, the DHHS Secretary has great power over any international drug control proposal, because he is required to "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." In other words, if the U.N. Commission on Narcotic Drugs proposes rescheduling marijuana under the Single Convention on Narcotic Drugs, the DHHS Secretary's recommendation determines whether the U.S. will support or oppose that change[8] (http://www.usdoj.gov/dea/pubs/csa/811.htm).
History of marijuana rescheduling petitions
1972 petition
In 1972, the National Organization for the Reform of Marijuana Laws, or NORML, petitioned the Bureau of Narcotics and Dangerous Drugs, or BNDD (now the Drug Enforcement Administration, or DEA) to transfer marijuana to Schedule II so that it could be legally prescribed by physicians. The BNDD rejected the petition, finding that rescheduling would violate the United Nations Single Convention on Narcotic Substances.
In January 1974, NORML filed suit against the BNDD. The U.S. Second Court of Appeals reversed the Bureau's dismissal of the petition, remanding the case for reconsideration. In September 1975, the DEA acknowledged that treaty obligations did not prevent the rescheduling of marijuana but continued to refuse public hearings. In October 1980, the Court of Appeals remanded the NORML petition to the DEA for reconsideration for the third time.
1986 Hearings
Parties supporting 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.
Parties opposing rescheduling
- The Drug Enforcement Administration.
- The International 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. 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"[9] (http://www.druglibrary.org/olsen/MEDICAL/YOUNG/young1.html).
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.
On February 18, 1994, the D.C. Court of Appeals finally affirmed the DEA Administrator's power to overrule Judge Young's decision[10] (http://www.stopteenuse.com/pdf/090688_young_ruling_abstract.pdf). 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 petition
In 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 between 1988 and 1994.
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[11] (http://books.nap.edu/html/marimed/). 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[12] (http://www.usdoj.gov/dea/ongoing/marijuana.html). 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[13] (http://www.marijuananews.com/news.php3?sid=378).
In July 1999, Marinol, the prescription drug containing tetrahydrocannabinol, marijuana's active ingredient, was moved into the less-restrictive Schedule III, while marijuana was left in Schedule I[14] (http://www.marijuananews.com/marijuananews/cowan/jon_gettman_comments_on_the_resc.htm). The petitioners argued that the distinction between the two drugs was arbitrary, and that marijuana should be rescheduled as well. The DEA continued to support Marinol, however, as a method of THC ingestion without harmful smoke inhalation.
The DEA issued a final denial of Gettman's petition on March 20, 2001. The U.S. Court of Appeal upheld the agency's decision on March 24, 2002, ruling that the petitioners were not sufficiently injured to have standing to challenge DEA's determinations in federal court[15] (http://www.drugscience.org/arg.htm).
2002 petition
On October 9, 2002, the Coalition for Rescheduling Cannabis filed another petition[16] (http://www.drugscience.org/PR/10-9-02_filing.htm). 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." The text of that petition is available here (http://www.drugscience.org/index.htm).
Gettman speculates that if marijuana is removed from Schedule I, there are at least three possible ways in which the drug could be regulated:
Disputed interpretations of the Controlled Substances Act
The U.S. Government and Jon Gettman have opposing interpretations of the Controlled Substances Act. DEA Administrator Donnie Marshall's letter announcing the DEA's denial of the 1995 petition, published in the April 18, 2001 Federal Register, provides considerable insight into the Government's interpretation of several key provisions of the Act[17] (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register&docid=01-9306-filed). Since the appeal of that decision was dismissed by the Court of Appeals on a technicality, it is unclear which interpretation the Court would ultimately side with if the 2002 petition were to be reviewed by the Court.
Proper classification of drugs with no accepted medical use and low potential for abuse
Gettman's position is that a drug cannot remain in a Schedule unless it fully meets all three statutory criteria for that Schedule. But the DEA interprets the Controlled Substances Act to mean that if a drug with no accepted medical use has even a low abuse potential - for instance, equivalent to a Schedule V drug - 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).
According to this interpretation, if the Government finds that marijuana has no accepted medical use, then the drug must remain in Schedule I regardless of the degree of its potential for abuse.
Meaning of "high potential for abuse"
Gettman believes that "high potential for abuse" means that a drug has a potential for abuse similar to that of cocaine or heroin. Gettman argues further that since laboratory animals do not self-administer marijuana, marijuana has less potential for abuse than cocaine and heroin. The Food and Drug Administration interprets the widespread use of marijuana as evidence of its potential for "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 Department of Health and Human Services rejects the argument that laboratory animals' failure to self-administer marijuana and the relatively mild physiological effects of the drug are proof of a lesser potential for abuse than cocaine, heroin and other Schedule I drugs:
- 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.
- 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.
Thus, the Government considers marijuana use statistics to be more important than biological studies in determining that marijuana has a "high potential for abuse".
References
- Coalition Files Federal Administrative Petition To Legalize Medical Marijuana (http://www.norml.org/index.cfm?Group_ID=5427), NORML News, Oct. 10, 2002.
- Controlled Substances Act (http://www.usdoj.gov/dea/pubs/csa.html).
- DEA Accepts Rescheduling Petition (http://www.letfreedomgrow.com/articles/reschedule_cannabis2.htm), American Alliance for Medical Cannabis, Apr. 15, 2003.
- Exposing the Myth of Smoked Medical Marijuana (http://www.usdoj.gov/dea/ongoing/marijuana.html), Drug Enforcement Administration, 2001.
- Gamma Hydroxybutyrate (GHB) (http://www.whitehousedrugpolicy.gov/publications/factsht/gamma/), ONDCP Drug Policy Information Clearinghouse, Nov. 2002.
- Gettman, Jon; petition to reschedule marijuana denied, 2003720076 (http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register&docid=01-9306-filed), Federal Register, Mar. 28, 2001.
- Gettman, Jon: Science and the End of Marijuana Prohibition (http://www.marijuananews.com/marijuananews/cowan/science_and_the_end_of_marijuana.htm), May 13, 1999.
- Gettman v. DEA - Government Response (http://www.norml.org/index.cfm?Group_ID=5088)
- Grinspoon, Lester and Bakalar, James B.: The History of Cannabis (http://www.a1b2c3.com/drugs/mj019a.htm), From the book Marihuana, the Forbidden Medicine, Yale University, 1993.
- High Court Upholds Marijuana as Dangerous Drug (http://216.167.102.130/DEAPressRelease6-6-02.htm), Drug Enforcement Administration, June 6, 2002.
- Jon Gettman Comments On The Rescheduling of Marinol (http://www.marijuananews.com/marijuananews/cowan/jon_gettman_comments_on_the_resc.htm), MarijuanaNews, July 27, 1999.
- Kuipers, Dean: Burnt: Medical use of marijuana has been legal in California since 1996 (http://www.safeaccessnow.org/article.php?id=679), June 25, 2003.
- Marijuana and Medicine: Assessing the Science Base (http://books.nap.edu/html/marimed/), Institute of Medicine, 1999.
- Medicinal marijuana: the struggle for legalization (http://edition.cnn.com/HEALTH/9702/weed.wars/issues/background/), CNN Interactive, 1997.
- Sense of Congress Regarding Marijuana (http://www.marijuananews.com/congressional_record_on_the_hous.htm), Congressional Record, Sep. 15, 1998.
|