05577-fedreg041801

Wednesday, April 18, 2001

Part II

Department of Justice

Drug Enforcement Agency Denial of Petition; Notice

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/Vol. 66, No. 75/Wednesday, April 18, 2001/Notices

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As set for in a memorandum of understandingentered in to by HHS, the Food and DrugAdministration (FDA), and the National Institute onDrug Abuse (NIDA), FDA acts as the lead agencywithin HHS in carrying out the Secretary’sscheduling responsibilities under the CAS, with theconcurrence of NIDA. 50 FR 9518 (1985).

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To avoid confusion, those parts of the HHSdocument that are not relevant to your petition withrespect to marijuana (

i.e.,

those parts that arerelevant only to the scheduling of tetrahydrocannabinols, dronabinol, or nabilone)have been redacted from the attachment. The HHSevaluation of these other substances will beaddressed when DEA responds (in separate letters)to your petitions with respect to these othersubstances.

DEPARTMENT OF JUSTICEDrug Enforcement AdministrationNotice of Denial of Petition

By letter dated March 20, 2001, theDrug Enforcement Administration(DEA) denied a petition to initiaterulemaking proceedings to reschedulemarijuana. Because DEA believes thatthis matter is of particular interest tomembers of the public, the agency ispublishing below the letter sent to thepetitioner (denying the petition), alongwith the supporting documentation thatwas attached to the letter.

Dated: March 28, 2001.

Donnie R. Marshall,

Administrator.

U.S. Department of Justice,

Drug Enforcement Administration,Washington, D.C. 20537March 20, 2001. Jon Gettman:Dear Mr. Gettman: On July 10, 1995, youpetitioned the Drug EnforcementAdministration (DEA) to initiate rulemakingproceedings under the reschedulingprovisions of the Controlled Substances Act(CSA). Specifically, you petitioned DEA topropose rules, pursuant to 21 U.S.C. 811(a),that would amend the schedules of controlled substances with respect to thefollowing controlled substances: marijuana;tetrahydrocannabinols; dronabinol; andnabilone. Although you grouped thesesubstances together in your petition, thescheduling analysis differs for each. To avoidconfusion, DEA is providing you with aseparate response for each of the controlledsubstances that you proposed berescheduled. This letter responds to yourpetition to reschedule marijuana.

Summary

You requested that DEA remove marijuanafrom schedule I based on your assertion that‘‘there is no scientific evidence that [it has]sufficient abuse potential to warrant scheduleI or II status under the [CSA].’’ In accordancewith the CSA rescheduling provisions, DEAgathered the necessary data and forwardedthat information and your petition to theDepartment of Health and Human Services(HHS) for a scientific and medical evaluationand scheduling recommendation. HHSconcluded that marijuana does have a highpotential for abuse and thereforerecommended that marijuana remain inschedule I. Based on the HHS evaluation andall other relevant data, DEA has concludedthat there is no substantial evidence thatmarijuana should be removed from scheduleI. Accordingly, your petition to initiaterulemaking proceedings to reschedulemarijuana is hereby denied.

Detailed Explanation

A. Statutory Requirements and ProceduralHistoryThe CSA provides that the schedules of controlled substances established byCongress may be amended by the AttorneyGeneral in rulemaking proceedingsprescribed by the Administrative ProcedureAct. 21 U.S.C. 811(a). The Attorney Generalhas delegated this authority to theAdministrator of DEA. 28 CFR 0.100.As you have done, any interested partymay petition the Administrator to initiaterulemaking proceedings to reschedule acontrolled substance. 21 U.S.C. 811(a); 21CFR 1308.43(a). Before initiating suchproceedings, the Administrator must gatherthe necessary data and request from theSecretary of HHS a scientific and medicalevaluation and recommendation as towhether the controlled substance should berescheduled as the petitioner proposes. 21U.S.C. 811(b); 21 CFR 1308.43(d). TheSecretary has delegated this function to theAssistant Secretary for Health.

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The recommendations of the AssistantSecretary are binding on the Administratorwith respect to scientific and medicalmatters. Id. If the Administrator determinesthat the evaluations and recommendations of the Assistant Secretary and ‘‘all otherrelevant data’’ constitute substantial evidencethat the drug that is the subject of the petitionshould be subject to lesser control orremoved entirely from the schedules, he shallinitiate rulemaking proceedings toreschedule the drug or remove it from theschedules as the evidence dictates. 21 U.S.C.811(b); 21 CFR 1308.43(e). In making such adetermination, the Administrator mustconsider eight factors:(1) The drug’s actual or relative potentialfor abuse;(2) Scientific evidence of itspharmacological effect, if known;(3) The state of current scientificknowledge regarding the drug;(4) Its history and current pattern of abuse;(5) The scope, duration, and significance of abuse;(6) What, if any, risk there is to the publichealth;(7) The drug’s psychic or physiologicaldependence liability; and(8) Whether the drug is an immediateprecursor of a substance already controlledunder the CSA.21 USC 811(c).In this case, you submitted your petition byletter dated March 10, 1995. After gatheringthe necessary data, DEA referred the petitionto HHS on December 17, 1997, and requestedfrom HHS a scientific and medical evaluationand scheduling recommendation. HHSforwarded its scientific and medicalevaluation and scheduling recommendationto DEA on January 17, 2001.B. HHS Scientific and Medical Evaluationand Other Relevant Data Considered by DEAAttached to this letter is the scientific andmedical evaluation and schedulingrecommendation that HHS submitted toDEA.

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Also attached is a document prepared by DEA that specifies other data relevant toyour petition that DEA considered.C. Basis for Denial of Your Petition: TheEvidence Demonstrates That Marijuana DoesHave A High Potential For AbuseYour petition rests on your contention thatmarijuana does not have a ‘‘high potential forabuse’’ commensurate with schedule I or IIof the CSA. The Assistant Secretary hasconcluded, based on current scientific andmedical evidence, that marijuana does havea high potential for abuse commensuratewith schedule I. The additional data gathered by DEA likewise reveals that marijuana hasa high potential for abuse. Indeed, when theHHS evaluation is viewed in combinationwith the additional data gathered by DEA,the evidence overwhelmingly leads to theconclusion that marijuana has a highpotential for abuse.Accordingly, there is no statutory basis forDEA to grant your petition to initiaterulemaking proceedings to reschedulemarijuana. For this reason alone, yourpetition must be denied.D. A Schedule I Drug With a High PotentialFor Abuse and No Currently AcceptedMedical Use or Safety for Use Must RemainClassified In Schedule IDEA’s denial of your petition is basedexclusively on the scientific and medicalfindings of HHS, with which DEA concurs,that lead to the conclusion that marijuana hasa high potential for abuse. Nonetheless,independent of this scientific and medical basis for denying your petition, there is alogical flaw in your proposal that should benoted.You do not assert in your petition thatmarijuana has a currently accepted medicaluse in treatment in the United States or thatmarijuana has an accepted safety for useunder medical supervision. Indeed, the HHSscientific and medical evaluation reaffirmsexpressly that marijuana has no currentlyaccepted medical use in treatment in theUnited States and a lack of accepted safetyfor use under medical supervision.Nor do you dispute that marijuana is adrug of abuse. That is, you do not contendthat marijuana has no potential for abusesuch that it should be removed entirely fromthe CSA schedules. Rather, your contentionis that marijuana has less than a ‘‘highpotential for abuse’’ commensurate withschedules I and II and, therefore, it cannot beclassified in either of these two schedules.Congress established only one schedule—schedule I—for drugs of abuse with ‘‘nocurrently accepted medical use in treatmentin the United States’’ and ‘‘lack of acceptedsafety for use *** under medicalsupervision.’’ 21 USC 812(b). To be classifiedin schedules II through V, a drug of abuse

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A controlled substance in schedule II must haveeither

‘‘

a currently accepted medical use intreatment in the United States or a currentlyaccepted medical use with severe restrictions.

’’

21USC 812(b)(2)(B).

must have a

‘‘

currently accepted medical usein treatment in the United States.

’’

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Id.

Thisis why the CSA allows practitioners toprescribe only those controlled substancesthat are listed in schedules II through V. 21USC 829. Drugs listed in schedule I, bycontrast, may not be prescribed for patientuse; they may only be dispensed bypractitioners who are conducting FDA-approved research and have obtained aschedule I research registration from DEA. 21USC 823(f); 21 CFR 5.10(a)(9), 1301.18,1301.32.That schedule I controlled substances arecharacterized by a lack of accepted medicaluse was recently reiterated by Congress,when it declared, in a provision entitled,

‘‘

NOT LEGALIZING MARIJUANA FORMEDICINAL USE

’’

:It is the sense of the Congress that

—

(1) certain drugs are listed on Schedule Iof the Controlled Substances Act if they havea high potential for abuse, lack any currentlyaccepted medical use in treatment, and areunsafe, even under medical supervision;(2) the consequences of illegal use of Schedule I drugs are well documented,particularly with regard to physical health,highway safety, and criminal activity;(3) pursuant to section 401 of theControlled Substances Act, it is illegal tomanufacture, distribute, or dispensemarijuana, heroin, LSD, and more than 100other Schedule I drugs;(4) pursuant to section 505 of the FederalFood, Drug and Cosmetic Act, before anydrug can be approved as a medication in theUnited States, it must meet extensivescientific and medical standards established by the Food and Drug Administration toensure it is safe and effective;(5)

marijuana and other Schedule I drugshave not been approved by the Food and Drug Administration to treat any disease or condition.

* * * * *

Pub. L. No. 105

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277, Div. F., 112 Stat. 2681

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760 to 2681

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761 (1998) (emphasis added).Thus, when it comes to a drug that iscurrently listed in schedule I, if it isundisputed that such drug has no currentlyaccepted medical use in treatment in theUnited States and a lack of accepted safetyfor use under medical supervision, and it isfurther undisputed that the drug has at leastsome potential for abuse sufficient to warrantcontrol under the CSA, the drug must remainin schedule I. In such circumstances,placement of the drug in schedules II throughV would conflict with the CSA since suchdrug would not meet the criterion of

‘‘

acurrently accepted medical use in treatmentin the United States.

’’

21 USC 812(b).Therefore, even if one were to assume,theoretically, that your assertions aboutmarijuana

’

s potential for abuse were correct(

i.e.,

that marijuana had some potential forabuse but less than the

‘‘

high potential forabuse

’’

commensurate with schedules I andII), marijuana would not meet the criteria forplacement in schedules III through V since ithas no currently accepted medical use intreatment in the United States

—

adetermination that is reaffirmed by HHS inthe attached medical and scientificevaluation.For the foregoing reasons, your petition toreschedule marijuana cannot be grantedunder the CSA and is, therefore, denied.Sincerely,Donnie R. Marshall,

Administrator.

Attachments.

Department of Health and Human Services,

Office of the Secretary, Office of the PublicHealth and Science, Assistant Secretary forHealth, Surgeon General, Washington, D.C.20201. January 17, 2001.Mr. Donnie R. Marshall,

Deputy Administrator, Drug Enforcement Administration, Washington, D.C. 20537.

Dear Mr. Marshall: In response to yourrequest dated December 17, 1997, andpursuant to the Controlled Substances Act(CSA), 21 U.S.C.

§

811 (b), (c), and (f), theDepartment of Health and Human Services(DHHS) recommends that marijuana ***continue to be subject to control underSchedule I. *** Marijuana and thetetrahydrocannabinols are currentlycontrolled under Schedule I of the CSA.Marijuana continues to meet the three criteriafor placing a substance in Schedule I of theCSA under 21 U.S.C. 812(b)(1). As discussedin the attached analysis, marijuana has a highpotential for abuse, has no currently acceptedmedical use in treatment in the UnitedStates, and has a lack of accepted safety foruse under medical supervision. Accordingly,HHS recommends that marijuana ***continue to be subject to control underSchedule I of the CSA.You will find enclosed two documentsprepared by FDA

’

s Controlled SubstanceStaff that are the bases for therecommendations.Sincerely yours,David Satcher,

Assistant Secretary for Health and SurgeonGeneral.

Enclosure.

Basis for the Recommendation forMaintaining Marijuana in Schedule I of the Controlled Substances Act

A. Background

On July 10, 1995, Mr. Jon Gettmansubmitted a petition to the DrugEnforcement Administration (DEA)requesting that proceedings be initiatedto repeal the rules and regulations thatplace marijuana and thetetrahydrocannabinols in Schedule I of the Controlled Substances Act (CSA)and dronabinol and nabilone inSchedule II of the CSA. The petitioncontends that evidence of abusepotential is insufficient for eachsubstance or class of substances to becontrolled in Schedule I or II of theCSA. In December 1997, the DEAAdministrator requested that theDepartment of Health and HumanServices (DHHS) develop scientific andmedical evaluations andrecommendations as to the properscheduling of the substances at issue,pursuant to 21 U.S.C. 811(b).This document responds to theportion of the petition that concernsmarijuana ***.In accordance with 21 U.S.C. 811(b),the DEA has gathered information, andthe Secretary of DHHS has consideredeight factors in a scientific and medicalevaluation, to determine how toschedule and control marijuana(Cannabis sativa) under the CSA. Theeight factors are: actual or relativepotential for abuse, scientific evidenceof pharmacological effects, scientificknowledge about the drug or substancein general, history and current patternsof abuse, the scope and duration andsignificance of abuse, the risk (if any) topublic health, psychic or physiologicdependence liability, and whether thesubstance is an immediate precursor of a substance that is already controlled. If appropriate, the Secretary must alsomake three findings

—

related to asubstance

’

s abuse potential, legitimatemedical use, and safety or dependenceliability

—

and then a recommendation.This evaluation presents scientific andmedical knowledge under the eightfactors, findings in the three requiredareas, and a recommendation.Administrative responsibilities forevaluating a substance for control underthe CSA are performed by the Food andDrug Administration (FDA), with theconcurrence of the National Institute onDrug Abuse (NIDA), as described in theMemorandum of Understanding (MOU)of March 8, 1985 (50 FR 9518

–

20).Pursuant to 21 U.S.C. 811(c), the eightfactors pertaining to the scheduling of marijuana are considered below. Theweight of the scientific and medicalevidence considered under these factorssupports the three findings that: (1)Marijuana has a high potential forabuse, (2) marijuana has no currentlyaccepted medical use in treatment in theUnited States, and (3) there is a lack of accepted evidence about the safety of using marijuana under medicalsupervision.

B. Evaluating Marijuana Under theEight Factors

This section presents scientific andmedical knowledge about marijuanaunder the eight required factors.