UNITED STATES DEPARTMENT OF JUSTICE

                     Drug Enforcement Administration

______________________________
In the Matter of              )
                              )
                              )
PETITION OF CARL ERIC OLSEN   )                On Remand From the
                              )                United States Court
                              )                of Appeals for the
                              )                District of Columbia
______________________________)                Circuit, No. 93-1109


                               FINAL ORDER


     This order is issued pursuant to an Order dated December 9, 1993, 

from the United States Court of Appeals for the District of Columbia 

Circuit which remanded the matter of a petition from Carl Eric Olsen to 

the Drug Enforcement Administration (DEA) for a ruling by the agency.

     On September 6, 1992, Carl Eric Olsen (Petitioner) of Des Moines, 

Iowa, submitted a petition requesting that the controlled substance 

marijuana, be rescheduled from Schedule I to Schedule II of the 

Controlled Substances Act of 1970 (CSA).  The Petitioner's grounds 

were based on his evaluation of two prior rescheduling actions by the 

Administrator.  See Rescheduling of Synthetic Dronabinol in Sesame Oil 

and Encapsulated in Soft Gelatin Capsules, 51 Fed. Reg. 17476 (1986) and 

Marijuana Rescheduling Petition, 57 Fed. Reg. 10499 (1992).  On October 

23, 1992, the-Administrator of Drug Enforcement, Robert C. Bonner, 

declined to accept his petition.  The Petitioner subsequently filed for 

review of then-Administrator Bonner's decision with the United States 

Court of Appeals for the District of Columbia

Circuit.  The matter was remanded by Order of that Court to the DEA for a 

ruling.  Pursuant to that Court's Order, and 21 C.F.R.  1308.44(c), the 

Deputy Administrator of the Drug Enforcement Administration has 

considered the matters before him and thereby renders his final decision.

     In his Petition for rescheduling, the Petitioner alleged that 

marijuana need not have an accepted medical use in treatment in the 

United States in order to be rescheduled from Schedule I, but "it only 

needs to be shown that marijuana is a source for an accepted and useful 

medication".  This contention was based on Petitioner's own analogies 

drawn from an earlier DEA marijuana rescheduling case, 57 Fed. Reg. 10499 

(1992), and subsequent written statements made to the Petitioner by then-

Administrator Bonner regarding coca leaves and opium plant material; and 

the Petitioner's incorrect contention that the DEA proposed to reschedule 

dronabinol in a proposed rulemaking.  See Rescheduling of Synthetic 

Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules, 50 

Fed. Reg. 42186 (1985).  It appears that Petitioner contends that this 

rescheduling action included delta-9-tetrahydrocannabinol (delta-9-THC), 

an ingredient in marijuana, and concluded that "since marijuana is now a 

source for an accepted and useful medication, it must now be rescheduled 

from Schedule I to Schedule II of the CSA".

     The Deputy Administrator finds, for the reasons stated herein, that 

the grounds upon which the Petitioner relies are not 


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sufficient to justify the initiation of proceedings for the transfer of 

marijuana from Schedule I to Schedule II of the CSA. 

     In July 1992, the Petitioner wrote then-Administrator Bonner 

regarding his final order of March 26, 1992, (57 Fed. Reg. 10499), in 

which the Administrator declined to reschedule marijuana to Schedule II, 

and the apparent "unfair" classification of the marijuana plant as a 

Schedule I substance, while coca and opium plants remained in Schedule 

II.  Then-Administrator Bonner replied by letter on August 17, 1992, and 

distinguished the pharmaceuticals or derivative compounds from each 

plant.  Apparently, the Petitioner then created a theory, that given 

that the Schedule II opium and coca plants were a source for accepted 

medication, then if marijuana plants were a source for accepted 

medications it should also be a Schedule II substance.  To further his 

argument, the Petitioner pointed to the rescheduled drug, which he 

called dronabinol, as having its source in marijuana.  The Petitioner 

also alluded to inconsistencies of scheduling of delta-9-THC, a 

component of marijuana, between the CSA and certain multilateral 

international agreements.

     When the CSA was created, Congress specified the initial scheduling 

of controlled substances and the criteria by which controlled substances 

could be rescheduled.  21 U.S.C.  811-812.  The DEA is bound, by law, 

to follow this mandate.  Congress placed both the tetrahydrocannabinols, 

which includes delta-9-THC, and the plant marijuana into Schedule I when 

it enacted the


                                    3

CSA.  See Pub. L. 91-513,  202(c), Schedule I (c)(17) and (c)(10). 

Similarly, Congress placed opium poppy and straw and coca leaves into 

Schedule II.  See Pub. L. 91-513,  202(c), Schedule II (a)(3) and 

 (a)(4).  The legislative history indicates that marijuana was placed 

into Schedule I on its own merits and not because delta-9-THC could be 

extracted from it.  H.R. Rep. No. 1444, 91st Cong., 2d Sess., pt. 1, at 

12 (1970).

     Whether or not marijuana is a source of delta-9-THC is irrelevant to 

the status of marijuana under the CSA.  With regard to the classification 

of controlled substances, the Attorney General may, by rule, add to the 

established schedules or transfer between such schedules and drug or 

other substance if [s]he finds that such drug or other substance has a 

potential for abuse, and makes with respect to such drug or other 

substance the findings prescribed by subsection (b) of Section 812 for 

the schedule in which such drug is to be placed.  21 U.S.C.  811(a)(1). 

The Attorney General has delegated this authority to the Administrator, 

who has redelegated it to the Deputy Administrator.  See 28 C.F.R.  

0.100(b) and 0.104.  (59 Fed. Reg. 23637 (May 6, 1994)).

     In order for a substance to be placed into Schedule II, the 

Attorney General must find that:  "(A) The drug or other substance has a 

high potential for abuse.  (B) 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.  (C) Abuse of 

the drug or other substance may lead


                                    4

 to severe psychological or physical dependence."  21 U.S.C.  812(b)(2).

     Then-Administrator John C. Lawn previously determined that marijuana 

does not have a currently accepted medical use in treatment in the United 

States and as a result must remain in Schedule I.  See Marijuana 

Rescheduling Petition, 54 Fed. Reg. 53767 (1989).  Then-Administrator 

Lawn's final order was appealed to the United States Circuit Court of 

Appeals for the D.C. Circuit which returned the matter to the DEA for an 

explanation of the factors relied upon in determining "currently accepted 

medical use".  See Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 

936 (D.C. Cir. 1991).

     In response to the remand, then-Administrator Bonner issued a final 

order in which he determined that for a substance to have a "currently 

accepted medical use" the following must exist: 

     a.   the drug's chemistry must be known and reproducible; 

     b.   there must be adequate safety studies; 

     c.   there must be adequate and well-controlled studies proving 

          efficacy; 

     d.   the drug must be accepted by qualified experts; and

     e.   the scientific evidence must be widely available. 

Then-Administrator Bonner concluded that marijuana failed to meet all 

elements of the five-part test and, therefore, did not meet the 

statutorily prescribed criteria for a Schedule II substance. 

Marijuana Rescheduling Petition, 57 Fed. Reg. 10499 (1992); See 


                                  5

Alliance for Cannabis Therapeutics v. DEA, et al., 15 F.3d 1131 (D.C. 

Cir. 1994) upholding the Administrator's decision. 

     Accordingly, the Deputy Administrator concludes that the 

Petitioner's contention that marijuana need not have an accepted 

medical use in treatment in the United States in order to be 

rescheduled from Schedule I to Schedule II of the CSA is not in 

accordance with law.  DEA may only move a drug from Schedule I if 

there is a finding of "currently accepted medical use in treatment in 

the United States".

     Although delta-9-THC is the principle psychoactive ingredient in 

marijuana, it can be synthesized and exist as a chemical. Delta-9-THC 

is a generic term which refers to four separate chemicals and two 

mixtures of chemicals, i.e., four stereochemical variants of the 

parent substance and two racemates.  One of the stereochemical 

variants, the (-) delta-9-trans-THC isomer, is the principle 

psychoactive ingredient in Cannabis sativa, L., or marijuana.  That 

isomer is also the ingredient in a pharmaceutical product which has 

been shown to be safe and effective as an anti-emetic for certain 

patients receiving cancer chemotherapy, and is identified chemically 

as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-

dibenzo[b,d]-pyran-1-ol.  The International Nonproprietary name (INN) 

and the U.S. Adopted Name (USAN) for that isomer of delta-9-THC is 

dronabinol. 

     With the development of scientific and medical evidence that 

demonstrated that a pharmaceutical product which contained


                                  6

dronabinol was safe and effective for the treatment of nausea and 

vomiting associated with cancer chemotherapy in certain patients, 

then-Administrator John C. Lawn rescheduled this pharmaceutical 

product from Schedule I to Schedule II. See 51 Fed. Reg. 17476 

 (1986).  Only the pharmaceutical product was transferred from 

Schedule I to Schedule II, i.e., "dronabinol (synthetic) in sesame 

oil and encapsulated in soft gelatin capsules in a U.S. Food and Drug 

Administration approved drug product".  No rescheduling action was 

taken with regard to (-) delta-9-trans-THC, i.e., dronabinol, which 

remains in Schedule I of the CSA. Tetrahydrocannabinols, including 

delta-9-THC, one of the synthetic equivalents of the substances 

contained in the plant or resinous extractives of Cannabis 

(marijuana) are listed at 21 C.F.R.  1308.11(d)(25). 

     Tetrahydrocannabinols and all their isomers, including delta-9-

THC, are also the subject of control by international agreement under 

the United Nations Convention on Psychotropic Substances, 1971, 

February 21, 1971, 32 U.S.T. 543, T.I.A.S. 9725, 1019 U.N.T.S. 175. 

Cannabis, cannabis resin and extracts and tinctures of cannabis are 

regulated as Schedule I substances under the United Nations Single 

Convention on Narcotic Drugs, 1961, March 30, 1961, 18 U.S.T. 1407, 

T.I.A.S. 6298, 520 U.N.T.S. 204. The United States is a party to both 

conventions.

     Then-Administrator Lawn also discussed the United States 

international obligations in his Dronabinol in Sesame Oil and 

Encapsulated in a Soft Gelatin Capsule, rescheduling action. 


                                  7

See 51 Fed. Reg. 17476 (1986). Since Article 7 of the Convention on 

Psychotropic Substances, 1971 has strict prohibitions on activities 

involving Schedule I drugs, in 1987, the United States Government 

initiated an action to have delta-9-THC transferred to Schedule II to 

allow the pharmaceutical product to be marketed. See U.N. Doc. 

E/CN.7/1990/4.  Such a transfer was not inconsistent with the 

substance delta-9-THC remaining in the CSA Schedule I. Under Article 

23 of the Convention on Psychotropic Substances, 1971, a party may 

adopt more strict or severe measures of control if desirable or 

necessary for the protection of the public health and welfare. 

     Under the CSA, the regulation of chemicals and the plant 

material are distinct from each other. The classification of delta-9-

THC has no bearing on the classification of marijuana. Under the CSA, 

a proposed change in the schedule of either a tetrahydrocannabinol or 

the plant marijuana requires the Attorney General to proceed 

independently. 

     Petitioner apparently does not wish to look to the clear 

construct of the Controlled Substances Act, but to pose alternative 

theories of the Act.  Under the CSA, drugs or other substances may be 

treated and classified differently, according to the enumerated 

statutory criteria. 21 U.S.C.  812(b). 

     The Deputy Administrator reaffirms that marijuana does not have 

a currently accepted medical use in treatment in the United States 

and is thus appropriately listed as a Schedule I controlled 

substance. The Deputy Administrator finds nothing to


                                  8

support the petitioner's contention that since marijuana, coca, and 

opium are all plant materials they must be treated alike in the CSA. 

The Deputy Administrator further finds that the rescheduling of the 

pharmaceutical product "dronabinol (synthetic) in sesame oil and 

encapsulated in a soft gelatin capsule in a U.S. Food and Drug 

Administration approved drug product", which contains the synthetic 

chemical ingredient (-) delta-9-trans-THC, did not require that 

either the plant marijuana or substance delta-9-THC be similarly 

rescheduled. The Petitioner's request is denied. 

      Stephen H. Greene
      Deputy Administrator

Dated: May 16, 1994 


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