HaCKeRz Kr0nlcKLeZ 1/HaCKeRz Kr0nlcKLeZ.iso/drugs/dea.ruling

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From: [e-mail]
Newsgroups: talk.politics.drugs
Subject: DEA MARIJUANA RULING
Date: 20 May 1994 21:06:26 GMT
Message-ID: <2rj8oi$[e-mail]>

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 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 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 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 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]-p
yran-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 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.  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 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

=============================================================================

From: [e-mail]
Newsgroups: talk.politics.drugs
Subject: REPLY TO DEA RULING
Date: 24 May 1994 16:23:11 GMT
Message-ID: <2rt9lf$[e-mail]>

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

PRELIMINARY DRAFT OF APPEAL FROM FINAL ORDER
        On May 16, 1994, the Deputy Administrator of the Drug Enforcement
Administration (DEA) erroneously denied my petition to have marijuana
transferred from Schedule I to Schedule II of the Controlled Substances Act
(CSA), 21 U.S.C. '' 801 et seq.  The DEA Deputy Administrator erred by
erroneously ruling that: (1) marijuana must have a medical use in treatment
in the United States before it can be transferred to Schedule II of the CSA;
(2) only synthetic dronabinol in sesame oil and encapsulated in soft gelatin
capsules, not dronabinol itself, was transferred to Schedule II of the CSA;
and (3) whether or not marijuana is a source of delta-9-tetrahydrocannabinol
(THC) is irrelevant to the status of marijuana under the CSA.
        In my petition for rescheduling, I 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".  In his final
ruling, the DEA Deputy Administrator said, "This contention was based on
Petitioners 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;..."  FINAL ORDER, at page 2 (May 16, 1994).
        The DEA Deputy Administrator cites the case of Alliance for Cannabis
Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) to support his theory
that marijuana may only be moved from Schedule I if there is a finding of
"currently accepted medical use in treatment in the United States."  The
parties agreed that nothing which has a currently accepted medical use in
treatment can be included in Schedule I, and the question of whether
marijuana has a currently accepted medical use in treatment was the sole
issue in that case.  The question of whether marijuana could be moved from
Schedule I without a currently accepted medical use in treatment was not an
issue in that case.  In 1977, the United States Court of Appeals for the
District of Columbia Circuit considered this exact question when it ruled,
"[P]lacement in Schedule I does not appear to flow inevitably from lack of
currently accepted medical use.  ...The legislative history of the CSA
indicates that medical use is but one factor to be considered, and by no
means the most important one."  National Organization for the Reform of
Marijuana Laws v. DEA, 559 F.2d 735, 748 (D.C. Cir. 1977).
        In my petition for rescheduling, I also allege 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).  In his final ruling the DEA Deputy
Administrator said, "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".  FINAL ORDER, at page 2.
        Although the DEA Deputy Administrator points out that I have
incorrectly identified dronabinol as delta-9-THC, the Deputy Administrator
admits that the correct ingredient, the (-) delta-9-trans-THC isomer of
delta-9-THC, is the principle psychoactive ingredient in Cannabis sativa,
L., or marijuana.  The Deputy Administrator argues that dronabinol was not
transferred to Schedule II of the CSA, and that only "dronabinol (synthetic)
in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and
Drug Administration approved drug product" has been transferred to Schedule
II of the CSA.  This is a distinction that the Deputy Administrator does not
have the authority to make.  FDA marketing approval is not a prerequisite
for the rescheduling of a drug.  Alliance for Cannabis Therapeutics v. DEA,
930 F.2d 936, 939-40 (D.C. Cir. 1991); Grinspoon v. DEA, 828 F.2d 881, 887
(1st Cir. 1987).  Certainly, the Deputy Administrator would not make the
claim that sesame oil and soft gelatin capsules, by themselves, belong in
any schedule of the CSA.  Is the Deputy Administrator saying that the
addition of sesame oil and soft gelatin capsules to dronabinol create
therapeutic value in dronabinol where none existed before, or that synthetic
dronabinol has therapeutic value while its twin obtained from the plant
material has none?
        The DEA Deputy Administrator points out that both delta-9-THC and
marijuana are subject to international control, delta-9-THC 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, and marijuana under the United
Nations Single Convention on Narcotic Drugs, 1961, March 30, 1961, 18 U.S.T.
543, T.I.A.S. 6298, 520 U.N.T.S. 204, and that the United States is a party
to both conventions.  In 1977, The United States Court of Appeals for the
District of Columbia Circuit ruled that the United States may place
marijuana in either Schedule I or Schedule II of the CSA without violating
its international obligations.  National Organization for the Reform of
Marijuana Laws v. DEA, 559 F.2d 735, 757 (D.C. Cir. 1977).
        The DEA Deputy Administrator admits, "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."
FINAL ORDER, at page 8.  The United States could have sought only the
transfer of "dronabinol (synthetic) in sesame oil and encapsulated in a soft
gelatin capsule in a U.S. Food and Drug Administration approved drug
product," but instead chose to seek the transfer of all delta-9-THC isomers
and racemates, whether obtained synthetically or from the plant material
itself.
        In his final ruling, the DEA Deputy Administrator said, "the
regulation of chemicals and the plant material are distinct from each
other."  FINAL ORDER, at page 8.  However, in a letter dated August 17,
1992, then DEA Administrator Robert C. Bonner said, "In placing coca leaves
and opium plant material in Schedule II, Congress was very much aware that
these plant materials have historically been recognized as the source for a
variety of accepted and useful medications."  Then Administrator Bonner
recognized, as the U.S. Supreme Court did in 1984, "If the intent of
Congress is clear, that is the end of the matter; for the court, as well as
the agency, must give effect to the unambiguously expressed intent of
Congress.  ...[I]f the statute is silent or ambiguous with respect to the
specific issue, the question for the court is whether the agencys answer is
based on a permissible construction of the statute."  Chevron U.S.A., Inc.
v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-843, 104 S.Ct.
2778, 2781-2782, 81 L.Ed.2d 694 (1984).  It is clear that Congress placed
coca and opium into Schedule II because they were sources for accepted and
useful medications, and it is equally clear that, "Neither of these plants
are used medicinally as plant material."  See DEA Administrator Bonners
letter of August 17, 1992.  Clearly, marijuana, like coca and opium, could
be placed in Schedule II without having a currently accepted medical use in
treatment in the United States and without violating international treaty
obligations.  It only needs to be shown that marijuana is the source of
accepted and useful medicines.  Investigations have also shown that other
drugs, other than (-) delta-9-trans-THC, in the marijuana plant may have
therapeutic value, but the placement of marijuana in Schedule I makes such
investigations difficult, if not impossible, which is why Congress chose to
place coca and opium in Schedule II rather than Schedule I.
        In his final ruling, the DEA Deputy Administrator said, "Whether or
not marijuana is a source of delta-9-THC is irrelevant to the status of
marijuana under the CSA."  FINAL ORDER, at page 4.  In 1975, the United
States Court of Appeals for the District of Columbia Circuit gave detailed
consideration to this question in the case of United States v. Walton, 514
F.2d 201 (D.C. Cir. 1975). The court said, "Looking at the history of this
latter law [the Marijuana Tax Act of 1937], we find that the definition of
marijuana was intended to include those parts of marijuana which contain THC
and to exclude those parts which do not."  Id. 514 F.2d at 203.  "The
legislative history is absolutely clear that Congress meant to outlaw all
plants popularly known as marijuana to the extent those plants possessed
THC."  Id. 514 F.2d at 203-204.  Although the Deputy Administrator said,
"The classification of delta-9-THC has no bearing on the classification of
marijuana." [FINAL ORDER, at page 8], the court has already ruled otherwise.
        Carl E. Olsen
May 24, 1994

Please send any comments or suggestions by email to Carl E. Olsen
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Thanks.  -- Carl