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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
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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
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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
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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
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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
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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.
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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
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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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