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                   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


                                     2

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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