359 lines
23 KiB
Plaintext
359 lines
23 KiB
Plaintext
From: carlolsen@dsm1.dsmnet.com
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Newsgroups: talk.politics.drugs
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Subject: DEA MARIJUANA RULING
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Date: 20 May 1994 21:06:26 GMT
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Message-ID: <2rj8oi$f4i@dsm6.dsmnet.com>
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UNITED STATES DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
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In the Matter of
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PETITION OF CARL ERIC OLSEN
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On Remand From the
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United States Court
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of Appeals for the
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District of Columbia
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Circuit, No. 93-1109
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FINAL ORDER
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This order is issued pursuant to an Order dated December 9, 1993,
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from the United States Court of Appeals for the District of Columbia Circuit
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which remanded the matter of a petition from Carl Eric Olsen to the Drug
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Enforcement Administration (DEA) for a ruling by the agency.
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On September 6, 1992, Carl Eric Olsen (Petitioner) of Des Moines,
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Iowa, submitted a petition requesting that the controlled substance
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marijuana, be rescheduled from Schedule I to Schedule II of the Controlled
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Substances Act of 1970 (CSA). The Petitioner's grounds were based on his
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evaluation of two prior rescheduling actions by the Administrator. See
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Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft
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Gelatin Capsules, 51 Fed. Reg. 17476 (1986) and Marijuana Rescheduling
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Petition, 57 Fed. Reg. 10499 (1992). On October 23, 1992, the-Administrator
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of Drug Enforcement, Robert C. Bonner, declined to accept his petition. The
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Petitioner subsequently filed for review of then-Administrator Bonner's
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decision with the United States Court of Appeals for the District of
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Columbia Circuit. The matter was remanded by Order of that Court to the DEA
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for a ruling. Pursuant to that Court's Order, and 21 C.F.R. ' 1308.44(c),
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the Deputy Administrator of the Drug Enforcement Administration has
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considered the matters before him and thereby renders his final decision.
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In his Petition for rescheduling, the Petitioner alleged that
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marijuana need not have an accepted medical use in treatment in the United
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States in order to be rescheduled from Schedule I, but "it only needs to be
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shown that marijuana is a source for an accepted and useful medication".
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This contention was based on Petitioner's own analogies drawn from an
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earlier DEA marijuana rescheduling case, 57 Fed. Reg. 10499 (1992), and
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subsequent written statements made to the Petitioner by then-Administrator
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Bonner regarding coca leaves and opium plant material; and the Petitioner's
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incorrect contention that the DEA proposed to reschedule dronabinol in a
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proposed rulemaking. See Rescheduling of Synthetic Dronabinol in Sesame Oil
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and Encapsulated in Soft Gelatin Capsules, 50 Fed. Reg. 42186 (1985). It
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appears that Petitioner contends that this rescheduling action included
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delta-9-tetrahydrocannabinol (delta-9-THC), an ingredient in marijuana, and
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concluded that "since marijuana is now a source for an accepted and useful
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medication, it must now be rescheduled from Schedule I to Schedule II of the
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CSA".
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The Deputy Administrator finds, for the reasons stated herein, that
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the grounds upon which the Petitioner relies are not sufficient to justify
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the initiation of proceedings for the transfer of marijuana from Schedule I
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to Schedule II of the CSA.
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In July 1992, the Petitioner wrote then-Administrator Bonner
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regarding his final order of March 26, 1992, (57 Fed. Reg. 10499), in which
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the Administrator declined to reschedule marijuana to Schedule II, and the
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apparent "unfair" classification of the marijuana plant as a Schedule I
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substance, while coca and opium plants remained in Schedule II.
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Then-Administrator Bonner replied by letter on August 17, 1992, and
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distinguished the pharmaceuticals or derivative compounds from each plant.
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Apparently, the Petitioner then created a theory, that given that the
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Schedule II opium and coca plants were a source for accepted medication,
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then if marijuana plants were a source for accepted medications it should
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also be a Schedule II substance. To further his argument, the Petitioner
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pointed to the rescheduled drug, which he called dronabinol, as having its
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source in marijuana. The Petitioner also alluded to inconsistencies of
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scheduling of delta-9-THC, a component of marijuana, between the CSA and
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certain multilateral international agreements.
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When the CSA was created, Congress specified the initial scheduling
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of controlled substances and the criteria by which controlled substances
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could be rescheduled. 21 U.S.C. '' 811-812. The DEA is bound, by law, to
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follow this mandate. Congress placed both the tetrahydrocannabinols, which
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includes delta-9-THC, and the plant marijuana into Schedule I when it
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enacted the CSA. See Pub. L. 91-513, ' 202(c), Schedule I (c)(17) and
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(c)(10). Similarly, Congress placed opium poppy and straw and coca leaves
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into Schedule II. See Pub. L. 91-513, ' 202(c), Schedule II (a)(3) and
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(a)(4). The legislative history indicates that marijuana was placed into
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Schedule I on its own merits and not because delta-9-THC could be extracted
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from it. H.R. Rep. No. 1444, 91st Cong., 2d Sess., pt. 1, at 12 (1970).
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Whether or not marijuana is a source of delta-9-THC is irrelevant to
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the status of marijuana under the CSA. With regard to the classification of
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controlled substances, the Attorney General may, by rule, add to the
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established schedules or transfer between such schedules and drug or other
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substance if [s]he finds that such drug or other substance has a potential
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for abuse, and makes with respect to such drug or other substance the
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findings prescribed by subsection (b) of Section 812 for the schedule in
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which such drug is to be placed. 21 U.S.C. ' 811(a)(1). The Attorney
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General has delegated this authority to the Administrator, who has
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redelegated it to the Deputy Administrator. See 28 C.F.R. '' 0.100(b) and
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0.104. (59 Fed. Reg. 23637 (May 6, 1994)).
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In order for a substance to be placed into Schedule II, the Attorney
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General must find that: "(A) The drug or other substance has a high
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potential for abuse. (B) The drug or other substance has a currently
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accepted medical use in treatment in the United States or a currently
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accepted medical use with severe restrictions. (C) Abuse of the drug or
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other substance may lead to severe psychological or physical dependence."
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21 U.S.C. ' 812(b)(2).
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Then-Administrator John C. Lawn previously determined that marijuana
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does not have a currently accepted medical use in treatment in the United
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States and as a result must remain in Schedule I. See Marijuana
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Rescheduling Petition, 54 Fed. Reg. 53767 (1989). Then-Administrator Lawn's
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final order was appealed to the United States Circuit Court of Appeals for
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the D.C. Circuit which returned the matter to the DEA for an explanation of
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the factors relied upon in determining "currently accepted medical use".
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See Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir.
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1991).
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In response to the remand, then-Administrator Bonner issued a final
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order in which he determined that for a substance to have a "currently
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accepted medical use" the following must exist:
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a. the drug's chemistry must be known and reproducible;
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b. there must be adequate safety studies;
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c. there must be adequate and well-controlled studies proving
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efficacy;
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d. the drug must be accepted by qualified experts; and
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e. the scientific evidence must be widely available.
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Then-Administrator Bonner concluded that marijuana failed to meet all
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elements of the five-part test and, therefore, did not meet the statutorily
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prescribed criteria for a Schedule II substance. Marijuana Rescheduling
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Petition, 57 Fed. Reg. 10499 (1992); See Alliance for Cannabis Therapeutics
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v. DEA, et al., 15 F.3d 1131 (D.C. Cir. 1994) upholding the Administrator's
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decision.
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Accordingly, the Deputy Administrator concludes that the
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Petitioner's contention that marijuana need not have an accepted medical use
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in treatment in the United States in order to be rescheduled from Schedule I
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to Schedule II of the CSA is not in accordance with law. DEA may only move
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a drug from Schedule I if there is a finding of "currently accepted medical
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use in treatment in the United states".
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Although delta-9-THC is the principle psychoactive ingredient in
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marijuana, it can be synthesized and exist as a chemical. Delta-9-THC is a
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generic term which refers to four separate chemicals and two mixtures of
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chemicals, i.e., four stereochemical variants of the parent substance and
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two racemates. One of the stereochemical variants, the (-)
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delta-9-trans-THC isomer, is the principle psychoactive ingredient in
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Cannabis sativa, L., or marijuana. That isomer is also the ingredient in a
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pharmaceutical product which has been shown to be safe and effective as an
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anti-emetic for certain patients receiving cancer chemotherapy, and is
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identified chemically as
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(6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-p
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yran-1-ol. The International Nonproprietary name (INN) and the U.S. Adopted
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Name (USAN) for that isomer of delta-9-THC is dronabinol.
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With the development of scientific and medical evidence that
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demonstrated that a pharmaceutical product which contained dronabinol was
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safe and effective for the treatment of nausea and vomiting associated with
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cancer chemotherapy in certain patients, then-Administrator John C. Lawn
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rescheduled this pharmaceutical product from Schedule I to Schedule II. See
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51 Fed. Reg. 17476 (1986). Only the pharmaceutical product was transferred
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from Schedule I to Schedule II, i.e., "dronabinol (synthetic) in sesame oil
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and encapsulated in soft gelatin capsules in a U.S. Food and Drug
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Administration approved drug product". No rescheduling action was taken
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with regard to (-) delta-9-trans-THC, i.e., dronabinol, which remains in
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Schedule I of the CSA. Tetrahydrocannabinols, including delta-9-THC, one of
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the synthetic equivalents of the substances contained in the plant or
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resinous extractives of Cannabis (marijuana) are listed at 21 C.F.R. '
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1308.11(d)(25).
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Tetrahydrocannabinols and all their isomers, including delta-9-THC,
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are also the subject of control by international agreement under the United
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Nations Convention on Psychotropic Substances, 1971, February 21, 1971, 32
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U.S.T. 543, T.I.A.S. 9725, 1019 U.N.T.S. 175. Cannabis, cannabis resin and
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extracts and tinctures of cannabis are regulated as Schedule I substances
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under the United Nations Single Convention on Narcotic Drugs, 1961, March
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30, 1961, 18 U.S.T. 1407, T.I.A.S. 6298, 520 U.N.T.S. 204. The United
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States is a party to both conventions.
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Then-Administrator Lawn also discussed the United States
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international obligations in his Dronabinol in Sesame Oil and Encapsulated
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in a Soft Gelatin Capsule, rescheduling action. See 51 Fed. Reg. 17476
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(1986). Since Article 7 of the Convention on Psychotropic Substances, 1971
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has strict prohibitions on activities involving Schedule I drugs, in 1987,
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the United States Government initiated an action to have delta-9-THC
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transferred to Schedule II to allow the pharmaceutical product to be
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marketed. See U.N. Doc. E/CN.7/1990/4. Such a transfer was not
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inconsistent with the substance delta-9-THC remaining in the CSA Schedule I.
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Under Article 23 of the Convention on Psychotropic Substances, 1971, a
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party may adopt more strict or severe measures of control if desirable or
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necessary for the protection of the public health and welfare.
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Under the CSA, the regulation of chemicals and the plant material
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are distinct from each other. The classification of delta-9-THC has no
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bearing on the classification of marijuana. Under the CSA, a proposed
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change in the schedule of either a tetrahydrocannabinol or the plant
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marijuana requires the Attorney General to proceed independently.
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Petitioner apparently does not wish to look to the clear construct
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of the Controlled Substances Act, but to pose alternative theories of the
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Act. Under the CSA, drugs or other substances may be treated and classified
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differently, according to the enumerated statutory criteria. 21 U.S.C. '
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812(b).
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The Deputy Administrator reaffirms that marijuana does not have a
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currently accepted medical use in treatment in the United States and is thus
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appropriately listed as a Schedule I controlled substance. The Deputy
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Administrator finds nothing to support the petitioner's contention that
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since marijuana, coca, and opium are all plant materials they must be
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treated alike in the CSA. The Deputy Administrator further finds that the
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rescheduling of the pharmaceutical product "dronabinol (synthetic) in sesame
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oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug
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Administration approved drug product", which contains the synthetic chemical
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ingredient (-) delta-9-trans-THC, did not require that either the plant
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marijuana or substance delta-9-THC be similarly rescheduled. The
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Petitioner's request is denied.
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Stephen H. Greene
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Deputy Administrator
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Dated: May 16, 1994
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=============================================================================
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From: carlolsen@dsm1.dsmnet.com
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Newsgroups: talk.politics.drugs
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Subject: REPLY TO DEA RULING
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Date: 24 May 1994 16:23:11 GMT
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Message-ID: <2rt9lf$o9p@dsm6.dsmnet.com>
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UNITED STATES DEPARTMENT OF JUSTICE
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Drug Enforcement Administration
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In the Matter of
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PETITION OF CARL ERIC OLSEN
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On Remand From the
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United States Court
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of Appeals for the
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District of Columbia
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Circuit, No. 93-1109
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PRELIMINARY DRAFT OF APPEAL FROM FINAL ORDER
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On May 16, 1994, the Deputy Administrator of the Drug Enforcement
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Administration (DEA) erroneously denied my petition to have marijuana
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transferred from Schedule I to Schedule II of the Controlled Substances Act
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(CSA), 21 U.S.C. '' 801 et seq. The DEA Deputy Administrator erred by
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erroneously ruling that: (1) marijuana must have a medical use in treatment
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in the United States before it can be transferred to Schedule II of the CSA;
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(2) only synthetic dronabinol in sesame oil and encapsulated in soft gelatin
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capsules, not dronabinol itself, was transferred to Schedule II of the CSA;
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and (3) whether or not marijuana is a source of delta-9-tetrahydrocannabinol
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(THC) is irrelevant to the status of marijuana under the CSA.
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In my petition for rescheduling, I alleged that marijuana need not
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have an accepted medical use in treatment in the United States in order to
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be rescheduled from Schedule I, but "it only needs to be shown that
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marijuana is a source for an accepted and useful medication". In his final
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ruling, the DEA Deputy Administrator said, "This contention was based on
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Petitioners own analogies drawn from an earlier DEA marijuana rescheduling
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case, 57 Fed. Reg. 10499 (1992), and subsequent written statements made to
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the Petitioner by then-Administrator Bonner regarding coca leaves and opium
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plant material;..." FINAL ORDER, at page 2 (May 16, 1994).
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The DEA Deputy Administrator cites the case of Alliance for Cannabis
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Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) to support his theory
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that marijuana may only be moved from Schedule I if there is a finding of
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"currently accepted medical use in treatment in the United States." The
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parties agreed that nothing which has a currently accepted medical use in
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treatment can be included in Schedule I, and the question of whether
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marijuana has a currently accepted medical use in treatment was the sole
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issue in that case. The question of whether marijuana could be moved from
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Schedule I without a currently accepted medical use in treatment was not an
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issue in that case. In 1977, the United States Court of Appeals for the
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District of Columbia Circuit considered this exact question when it ruled,
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"[P]lacement in Schedule I does not appear to flow inevitably from lack of
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currently accepted medical use. ...The legislative history of the CSA
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indicates that medical use is but one factor to be considered, and by no
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means the most important one." National Organization for the Reform of
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Marijuana Laws v. DEA, 559 F.2d 735, 748 (D.C. Cir. 1977).
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In my petition for rescheduling, I also allege that the DEA proposed
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to reschedule dronabinol in a proposed rulemaking. See Rescheduling of
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Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin
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Capsules, 50 Fed. Reg. 42186 (1985). In his final ruling the DEA Deputy
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Administrator said, "It appears that Petitioner contends that this
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rescheduling action included delta-9-tetrahydrocannabinol (delta-9-THC), an
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ingredient in marijuana, and concluded that since marijuana is now a source
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for an accepted and useful medication, it must now be rescheduled from
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Schedule I to Schedule II of the CSA". FINAL ORDER, at page 2.
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Although the DEA Deputy Administrator points out that I have
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incorrectly identified dronabinol as delta-9-THC, the Deputy Administrator
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admits that the correct ingredient, the (-) delta-9-trans-THC isomer of
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delta-9-THC, is the principle psychoactive ingredient in Cannabis sativa,
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L., or marijuana. The Deputy Administrator argues that dronabinol was not
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transferred to Schedule II of the CSA, and that only "dronabinol (synthetic)
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in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and
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Drug Administration approved drug product" has been transferred to Schedule
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II of the CSA. This is a distinction that the Deputy Administrator does not
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have the authority to make. FDA marketing approval is not a prerequisite
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for the rescheduling of a drug. Alliance for Cannabis Therapeutics v. DEA,
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930 F.2d 936, 939-40 (D.C. Cir. 1991); Grinspoon v. DEA, 828 F.2d 881, 887
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(1st Cir. 1987). Certainly, the Deputy Administrator would not make the
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claim that sesame oil and soft gelatin capsules, by themselves, belong in
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any schedule of the CSA. Is the Deputy Administrator saying that the
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addition of sesame oil and soft gelatin capsules to dronabinol create
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therapeutic value in dronabinol where none existed before, or that synthetic
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dronabinol has therapeutic value while its twin obtained from the plant
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material has none?
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The DEA Deputy Administrator points out that both delta-9-THC and
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marijuana are subject to international control, delta-9-THC under the United
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Nations Convention on Psychotropic Substances, 1971, February 21, 1971, 32
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U.S.T. 543, T.I.A.S. 9725, 1019 U.N.T.S. 175, and marijuana under the United
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Nations Single Convention on Narcotic Drugs, 1961, March 30, 1961, 18 U.S.T.
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543, T.I.A.S. 6298, 520 U.N.T.S. 204, and that the United States is a party
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to both conventions. In 1977, The United States Court of Appeals for the
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District of Columbia Circuit ruled that the United States may place
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marijuana in either Schedule I or Schedule II of the CSA without violating
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its international obligations. National Organization for the Reform of
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Marijuana Laws v. DEA, 559 F.2d 735, 757 (D.C. Cir. 1977).
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The DEA Deputy Administrator admits, "Since Article 7 of the
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Convention on Psychotropic Substances, 1971 has strict prohibitions on
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activities involving Schedule I drugs, in 1987, the United States Government
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initiated an action to have delta-9-THC transferred to Schedule II to allow
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the pharmaceutical product to be marketed. See U.N. Doc. E/CN.7/1990/4."
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FINAL ORDER, at page 8. The United States could have sought only the
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transfer of "dronabinol (synthetic) in sesame oil and encapsulated in a soft
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gelatin capsule in a U.S. Food and Drug Administration approved drug
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product," but instead chose to seek the transfer of all delta-9-THC isomers
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and racemates, whether obtained synthetically or from the plant material
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itself.
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In his final ruling, the DEA Deputy Administrator said, "the
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regulation of chemicals and the plant material are distinct from each
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other." FINAL ORDER, at page 8. However, in a letter dated August 17,
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1992, then DEA Administrator Robert C. Bonner said, "In placing coca leaves
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and opium plant material in Schedule II, Congress was very much aware that
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these plant materials have historically been recognized as the source for a
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variety of accepted and useful medications." Then Administrator Bonner
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recognized, as the U.S. Supreme Court did in 1984, "If the intent of
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Congress is clear, that is the end of the matter; for the court, as well as
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the agency, must give effect to the unambiguously expressed intent of
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Congress. ...[I]f the statute is silent or ambiguous with respect to the
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specific issue, the question for the court is whether the agencys answer is
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based on a permissible construction of the statute." Chevron U.S.A., Inc.
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v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-843, 104 S.Ct.
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2778, 2781-2782, 81 L.Ed.2d 694 (1984). It is clear that Congress placed
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coca and opium into Schedule II because they were sources for accepted and
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useful medications, and it is equally clear that, "Neither of these plants
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are used medicinally as plant material." See DEA Administrator Bonners
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letter of August 17, 1992. Clearly, marijuana, like coca and opium, could
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be placed in Schedule II without having a currently accepted medical use in
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treatment in the United States and without violating international treaty
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obligations. It only needs to be shown that marijuana is the source of
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accepted and useful medicines. Investigations have also shown that other
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drugs, other than (-) delta-9-trans-THC, in the marijuana plant may have
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therapeutic value, but the placement of marijuana in Schedule I makes such
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investigations difficult, if not impossible, which is why Congress chose to
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place coca and opium in Schedule II rather than Schedule I.
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In his final ruling, the DEA Deputy Administrator said, "Whether or
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not marijuana is a source of delta-9-THC is irrelevant to the status of
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marijuana under the CSA." FINAL ORDER, at page 4. In 1975, the United
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States Court of Appeals for the District of Columbia Circuit gave detailed
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consideration to this question in the case of United States v. Walton, 514
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F.2d 201 (D.C. Cir. 1975). The court said, "Looking at the history of this
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latter law [the Marijuana Tax Act of 1937], we find that the definition of
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marijuana was intended to include those parts of marijuana which contain THC
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and to exclude those parts which do not." Id. 514 F.2d at 203. "The
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legislative history is absolutely clear that Congress meant to outlaw all
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plants popularly known as marijuana to the extent those plants possessed
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THC." Id. 514 F.2d at 203-204. Although the Deputy Administrator said,
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"The classification of delta-9-THC has no bearing on the classification of
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marijuana." [FINAL ORDER, at page 8], the court has already ruled otherwise.
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Carl E. Olsen
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May 24, 1994
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Please send any comments or suggestions by email to Carl E. Olsen
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"carlolsen@dsm1.dsmnet.com" or "iowanorml@commonlink.com"
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Thanks. -- Carl
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