HaCKeRz Kr0nlcKLeZ 1/HaCKeRz Kr0nlcKLeZ.iso/drugs/olsen.v.dea

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From: [e-mail] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: Olsen v. DEA (1 of 7)
Date: Sat, 27 Aug 1994 13:18:45
Message-ID: <[e-mail]>

    Post Office Box 4091
    Des Moines, Iowa 50333
    July 21, 1992
Robert C. Bonner, Administrator
Drug Enforcement Administration
Washington, D.C. 20537
Dear Mr. Bonner:
    I just finished reading your decision on the Marijuana
Rescheduling Petition, 57 FR 10499 (March 26, 1992).  Your
explanation of the scheduling criteria in the Controlled
Substances Act (CSA) left me confused.  By your definition, a
substance in Schedule II is a scientifically established chemical
compound capable of reproduction in standardized dosages.  Of
course, marijuana is not such a substance, it is a plant, not a
drug.
    Although you made no mention of the fact, the coca plant,
from which cocaine is made, and the opium plant, from which
morphine and heroin are made, are both in Schedule II of the CSA.
As I was reading your decision, I wondered how these two plants
can be in Schedule II.  These plants are subject to the same
variances in chemistry as the marijuana plant.  It seems like you
are treating marijuana unfairly.
    If Congress intended to rely on scientifically established
chemistry and reproducible dosages, why did Congress include the
coca and opium plants in Schedule II?
    It seems to me that these plants should not be included in
the CSA at all, because they will never fit into your definition
of drugs, and I think your definition is correct as far as it
goes.  However, since Congress has decided to include them in the
CSA, your definition is inadequate to explain them.  I hope you
will correct your definition, and not simply ignore this apparent
inconsistency.
    Thank you for your attention.
    Sincerely,
    Carl Eric Olsen
    [phone]


August 17, 1992
Dear Mr. Olsen:
    This is in response to your letter of July 21, 1992,
regarding my decision with respect to the Marijuana Rescheduling
Petition.
    Your letter correctly states that one of the factors to be
considered in determining whether a substance has a currently
accepted medical use in treatment is that it is a scientifically
established chemical compound capable of reproduction is
standardized dosages.  While you are also correct in noting that
Congress placed coca and opium plant materials in Schedule II,
your attempt to analogize those substances to marijuana, and to
find inconsistency in their scheduling, fails.
    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.  Neither of these plants are
used medicinally as plant material.  In both instances, the
medically active alkaloids are extracted from the plant material
after which pharmaceutical compounds capable of reproduction in
standardized dosages are produced.  These compounds are the
medications which may then be lawfully marketed in the United
States.  While indigenous populations in various parts of the
world brew coca teas, chew coca leaves, and smoke opium for
various purposes, these practices are not permitted in the United
States under the Controlled Substances Act.
    Unlike pharmaceuticals derived from opium and coca leaves,
the petition to reschedule marijuana did not involve the
scheduling of any medically useful compound to be extracted from
the plant material.  Instead, the petition involved unsupported
claims for the medical use of smoked marijuana.  There is,
therefore, no inconsistency in my finding that such claims did
not make a case for accepted medical use in treatment in the
United States.
    Very truly yours,
    Robert C. Bonner
    Administrator of Drug Enforcement

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

From: [e-mail] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: Olsen v. DEA (2 of 7)
Date: Sat, 27 Aug 1994 13:22:02
Message-ID: <[e-mail]>

    Post Office Box 4091
    Des Moines, Iowa 50333
    September 6, 1992
Robert C. Bonner, Administrator
DrugEnforcement Administration
Washington, D.C. 20537
Dear Mr. Bonner:
    Carl Eric Olsen hereby petitions the Administrator to
reschedule marijuana from Schedule I to Schedule II of the
Controlled Substances Act (CSA) pursuant to Section 201 of the
CSA, Public Law 91-513, 21 U.S.C. º 811 and 21 C.F.R. º 1307.03.
    Attached hereto and constituting a part of this petition is
a statement of the grounds upon which petitioner relies for the
proposed rescheduling.
    Five copies of this petition are provided pursuant to 21
C.F.R. º 1308.44(b).
    All notices regarding this petition should be addressed to:
    Carl Eric Olsen
    Post Office Box 4091
    Des Moines, Iowa 50333
    [phone]
    Sincerely yours,
    Carl Eric Olsen
    [phone]


    PETITIONER'S STATEMENT OF GROUNDS FOR RESCHEDULING

    The Controlled Substances Act (CSA), 21 U.S.C. ºº 801 et
seq., contains five schedules, the first of which (Schedule I)
contains substances which have no medical use in treatment in the
United States, and the final four of which (Schedules II through
V) contain substances which have medical use in treatment in the
United States but which are available only by a physician's
prescription.  Marijuana is currently in Schedule I of the CSA.
    On March 26, 1992, the Administrator made a final decision
in a marijuana rescheduling petition, DEA No. 86-22, rejecting
the finding of an administrative law judge that marijuana has
medical use in treatment in the United States, and rejecting the
administrative law judge's recommendation that marijuana be moved
to Schedule II of the CSA.  57 FR 10499.
    The essence of the decision was that marijuana is a plant
and not a drug.  The Administrator argued that the chemistry of
the marijuana plant is complex, varies from plant to plant, and
is incapable of reproduction in standardized dosages (attributes
common to all plants), and that a drug is a scientifically
established chemical compound capable of reproduction in
standardized dosages.
    The Administrator's decision has been appealed to the United
States Court of Appeals for the District of Columbia by several
parties seeking medical access to marijuana plants.
    According to the Administrator, "the petition to reschedule
marijuana did not involve the scheduling of any medically useful
compound to be extracted from the plant material."  The
Administrator went on the say, "the petition involved unsupported
claims for medical use of smoked marijuana."  See Exhibit A.
    As for other plants in Schedule II, the Administrator 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."  The Administrator went on to
say, "Neither of these plants are used medicinally as plant
material."  See Exhibit A.
    It must follow from the Administrator's explanation 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, it only needs to be shown that marijuana
is a source for an accepted and useful medication.
    On October 11, 1985, the Administrator proposed to
reschedule dronabinol to Schedule II of the CSA.  50 FR 42186
(October 18, 1985); 21 C.F.R. º 1308.12(f)(1) (1991).  Dronabinol
is the synthetic equivalent of the isomer of delta-9-
tetrahydrocannabinol which is the principle psychoactive
substance present in Cannabis Sativa L., marijuana.  50 FR 42186
(October 18, 1985).
    Dronabinol is the U.S. Adopted Name (USAN) for the substance
(6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-
dibenzo [b,d] pyran-1-ol or (-)-delta-9-(trans)-
tetrahydrocannabinol, the principle psychoactive substance in
Cannabis sativa L., marijuana.  50 FR 42186 (October 18, 1985).
It has the empirical formula C21H30O2 with molecular weight of
314.45.  1989 Physician's Desk Reference, page 1859.
    On May 24, 1991, the United Nations Economic and Social
Council (ESCOR) rescheduled delta-9-tetrahydrocannabinol from
Schedule I to Schedule II of the 1971 Convention on Psychotropic
Substances.  U.N. Doc. E/CN.7/1991/26.  Report of the Commission
on Narcotic Drugs on its thirty-fourth session, U.N. Doc.
E/1991/24, Supp. No. 4.  The United States is a party to that
international convention pursuant to the Psychotropic Substances
Act of 1978 (Pub. L. 95-633, November 10, 1978).  50 FR 42186
(October 18, 1985).
    Since marijuana is now a source for an accepted and useful
medication, it must now be moved from Schedule I to Schedule II
of the CSA.

    Respectfully submitted,
    Carl Eric Olsen
    Post Office Box 4091
    Des Moines, Iowa 50333
    [phone]


October 23, 1992
Dear Mr. Olsen:
    This is in response to your petition to reschedule marijuana
from Schedule I to Schedule II of the Controlled Substances Act.
The crux of your petition is that marijuana itself need not have
an accepted medical use in treatment in the United States if it
is shown that marijuana is the source of an accepted and useful
medication.  To that end, you argue that marijuana should be
rescheduled as a source of delta-9-tetrahydrocannabinol because
dronabinol, the synthetic form of the same isomer, is controlled
in Schedule II.
    In a final rule published on May 13, 1986, then
Administrator John C. Lawn placed a very specific substance,
synthetic dronabinol in sesame oil and encapsulated in soft
gelatin capsules, in Schedule II.  Administrator Lawn's action
did not involve the rescheduling of delta-9-tetrahydrocannabinol
itself, nor did it include any form of dronabinol other than the
synthetic.  Accordingly, pursuant to 21 C.F.R. º 1308.44(c), your
petition to reschedule marijuana is not accepted.
    Since I am not accepting your petition on the grounds that
dronabinol is a wholly synthetic substance, not obtained from
marijuana, it is unnecessary for me to consider the broader
question of whether the rescheduling of marijuana would be
appropriate if accepted medications were indeed obtained from
that source.  As you are well aware, the issue of whether
marijuana itself has any accepted medical use is pending before
the United States Court of Appeals for the District of Columbia
Circuit.  We are confident that the Court will find no merit in
the petition and that it will affirm my ruling in that case.
    Very truly yours,
    Robert C. Bonner
    Administrator of Drug Enforcement




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From: [e-mail] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: Olsen v. DEA (3 of 7)
Date: Sat, 27 Aug 1994 13:25:22
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July 13, 1993
Dear Mr. Olsen:
    This replies to your May 13, 1993, letter asking several
questions about drugs.
    It is true that a good many drugs useful in therapeutics can
be extracted from herbs.  Some drugs have an animal origin, e.g.,
many hormones.  A synthetic drug is a drug that is made by
chemically combining various starting materials to make the
desired product.  The product is then identical in all respects
to the product isolated from a plant source.  Such a product can
be marketed under the same name.  For example, cortisone is
synthesized from a yam that grows in Mexico and it is identical
to cortisone extracted from adrenal tissue.
    A synthetic drug would be in the same schedule as its
naturally occurring twin.  For example, synthetic lysergic acid
amide is in the same schedule as lysergic acid amide derived from
the plant source.
    Please let me know if I can be of further assistance on drug
matters.
    Sincerely yours,
    Harold Davis
    Consumer Safety Officer
    CDER Executive Secretariat Staff (HFD-8)
    Center for Drug Evaluation and Research


December 2, 1993
Dear Mr. Olsen:
    This replies to your July 21, 1993, letter concerning
synthetic dronabinol (delta-9-THC).
    In respect to the naturally extracted and synthetically
manufactured dronabinol, the Drug Enforcement Agency has
promulgated the enclosed regulation.  Please note that
tetrahydrocannabinol is a Schedule I substance, but dronabinol,
synthetic, in sesame oil and in a soft gelatin capsule, is a U.S.
Food and Drug Administration approved drug product and is a
Schedule II substance.  Both marijuana and tetrahydrocannabinol
are Schedule I substances.
    With respect to your other questions on marijuana, the
original chemical researcher was Dr. Roger Adams of the
University of Illinois chemistry department.  The pharmacology of
the compounds was investigated by Dr. Seigried Lowe of the
University of Utah.  A review of marijuana is given on page 549-
553 of Goodman and Gilman's The Pharmacological Basis of
Therapeutics, 8th Edition, Pergamon Press, 1990.
    Sincerely yours,
    Harold Davis
    Consumer Safety Officer
    CDER Executive Secretariat Staff (HFD-8)
    Center for Drug Evaluation and Research

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

From: [e-mail] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: Olsen v. DEA (4 of 7)
Date: Sat, 27 Aug 1994 13:29:02
Message-ID: <[e-mail]>

MOTION FOR REMAND
    The Drug Enforcement Administration, respondent in the
above-captioned appeal, hereby moves this Court to remand the
action to the Administrator of the Drug Enforcement
Administration.  In support of this motion and as the basis
therefore, respondent states as follows:
    1.    On September 6, 1992, appellant Olsen filed a petition
with the Administrator requesting that marijuana be rescheduled
from Schedule I to Schedule II of the Controlled Substances Act.
In support of this petition, appellant filed a statement of
grounds for rescheduling in compliance with 21 C.F.R. º
1308.44(b)(B).
    2.    On October 23, 1992, the Administrator responded to
appellant's petition by refusing to accept that petition for
filing.  Prior to rejecting the petition for filing the
Administrator took no action to review the grounds upon which
appellant relied in that petition.
    3.    Pursuant to the 21 C.F.R. º 1308.44(c), respondent is
required to accept the petition for filing absent some defect in
format.  As this requirement was not met, respondent now requests
this Court to remand the matter so that respondent may accept
appellant's petition for filing and review that petition in
accordance with regulations.  See NORML v. Ingersoll, 497 F.2d
654 (D.C. Cir. 1974).
    4.    Respondent makes this motion in the interests of
fairness and judicial economy and not with the intent of causing
unnecessary delay.  Therefore, respondent respectfully requests
this Court to order the Administrator upon remand to accept
appellant's petition for filing and to make a ruling upon the
matter within 90 days of the date of this Court's final order in
the related cases of Alliance for Cannabis Therapeutics v. Drug
Enforcement Administration, No. 92-1168 and Drug Policy
Foundation v. Drug Enforcement Administration, No. 92-1179.  Both
of these cases are scheduled for oral argument on October 1,
1993.
    Respectfully submitted,
    Lena D. Mitchell
    Trial Attorney
    Narcotic and Dangerous Drug Section
    Criminal Division, P.O. Box 27312, Washington, D.C.  20530


RESPONSE TO
MOTION FOR REMAND
    I, Carl Eric Olsen, petitioner in the above-captioned
petition for review of a final administrative order, hereby
respond to the respondent's Motion for Remand to the
Administrator of the Drug Enforcement Administration, and state
as follows:
    1.    On September 6, 1992, I filed a petition with the
Administrator requesting that marijuana be rescheduled from
Schedule I to Schedule II of the Controlled Substances Act.  In
support of this petition, I filed a statement of grounds for
rescheduling in compliance with 21 C.F.R. º 1308.44(b)(B).
    2.    On October 23, 1992, the Administrator responded by
refusing to accept my petition for filing and by ruling on its
merits.  Contrary to what the respondent says in paragraph two of
the Motion for Remand, the Administrator did review the grounds
upon which I relied and did make a ruling on the merits of my
petition.
    3.    Pursuant to the 21 C.F.R. º 1308.44(c), respondent is
required to accept a petition for filing absent some defect in
format.  As the respondent now admits, this requirement was not
met, and respondent now claims it is requesting this Court to
remand the matter so that it may accept my petition for filing in
accordance with regulations.  However, since the respondent ruled
on the merits of my petition, it is questionable whether the
respondent actually refused to accept my petition for filing.
    4.    Respondent claims to make the Motion for Remand in the
interests of fairness and judicial economy and not with the
intent of causing unnecessary delay.  However, the respondent
fails to mention that the Drug Enforcement Administration (DEA)
has been developing a pattern of unfairness, waste of judicial
resources and unnecessary delay.  The respondent mentions one
example in the Motion for Remand, NORML v. Ingersoll, 497 F.2d
654 (D.C. Cir. 1974), but fails to mention another case where a
petition was not accepted for filing, Carl Eric Olsen v. Drug
Enforcement Administration, 878 F.2d 1458 (D.C. Cir 1989).
Between 1983 and 1985, I filed several petitions which the DEA
refused to accept, until a mandamus action was filed in the U.S.
District Court.  Id. 878 F.2d at 1459.  Then, after review of the
DEA's denial of the petition on its merits was sought, the DEA
asked this Court "to remand the matter for renewed agency
consideration."  Id. 878 F.2d at 1460.  This is exactly what the
DEA is doing now.
    5.    Since the DEA has already ruled on the merits of my
petition, the only possible reason for a remand would be because
the DEA didn't make a reasonable decision on the merits of my
petition and now wants to hold an administrative hearing before
an administrative law judge to correct its error.  If the DEA
simply plans to deny the petition again after it is accepted for
filing, then there is no reason for a remand, because a final
ruling has already been made and such a remand would simply be a
waste of judicial resources and an unnecessary delay.
    6.    Respondent now requests this Court to order the
Administrator upon remand to accept my petition for filing and to
make a ruling upon the matter within 90 days of the date of this
Court's final order in the related cases of Alliance for Cannabis
Therapeutics v. Drug Enforcement Administration, No. 92-1168 and
Drug Policy Foundation v. Drug Enforcement Administration, No.
92-1179.  Both of these cases are scheduled for oral argument on
October 1, 1993.  I strongly oppose my case being delayed for
these two cases.  The grounds upon which I seek rescheduling are
entirely unrelated to the grounds relied upon in these two cases,
and, if this Court decides to remand this matter, I think this
Court should set a time frame that is unrelated to them.
    Respectfully submitted,
    Carl E. Olsen, pro se
    Post Office Box 4091
    Des Moines, Iowa 50333

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

From: [e-mail] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: Olsen v. DEA (5 of 7)
Date: Sat, 27 Aug 1994 13:32:19
Message-ID: <[e-mail]>

November 17, 1993
Dear Senator Harkin:
    This is in response to your letter of October 12, 1993, on
behalf of your constituent, Mr. Carl E. Olsen.
    Pursuant to 21 U.S.C. º 811, and interested party can
petition the DEA to reschedule a controlled substance.  When such
a petition is filed with the Drug Enforcement Administration, it
is carefully evaluated to determine whether the petition meets
the requirements of 21 C.F.R. º 1308.44.  Section (b) of that
regulation requires that the petition conform to the format
provided and also specifies that four copies be filed.  If the
petition is accepted for filing, the Administrator will evaluate
the petition on its merits.  If the petition is not accepted for
filing, because it is either lacking in the regulatory
requirements or not readily understood, the Administrator will
notify the petitioner of his decision and reasons thereof.  21
C.F.R. º 1308.44(c).  A copy of the regulation has been provided
for your convenience.
    As you are aware, your constituent has appealed the DEA's
nonacceptance of his petition to the United States Court of
Appeals for the District of Columbia.  In that case, the DEA has
asked for a remand of the action in order that the Administrator
may accept Mr. Olsen's petition for filing and review that
petition on its merits.  The DEA is constrained from commenting
further on the merits of Mr. Olsen's case since it is currently
pending before the court of appeals.
    I hope the foregoing will assist you in responding to your
constituent.
    Sincerely,
    Stephen H. Greene
    Acting Administrator of Drug Enforcement


November 23, 1993
Dear Senator Grassley:
    This is in response to your letter of October 25, 1993, on
behalf of your constituent, Mr. Carl E. Olsen.
    As you are aware, your constituent has appealed the Drug
Enforcement Administration's (DEA) nonacceptance of his petition
to reschedule marijuana from Schedule I to Schedule II of the
Controlled Substances Act to the United States Court of Appeals
for the District of Columbia.  Pursuant to 21 U.S.C. º 811, and
interested party can petition the DEA to reschedule a controlled
substance.  When such a petition is filed with the Drug
Enforcement Administration, it is carefully evaluated to
determine whether the petition meets the requirements of 21
C.F.R. º 1308.44.  Section (b) of that regulation requires that
the petition conform to the format provided and be readily
understood.  If the petition is accepted for filing, the
Administrator will evaluate the petition on its merits.  If the
petition is not accepted for filing, the Administrator will
notify the petitioner of his decision and reasons thereof.  21
C.F.R. º 1308.44(c).  A copy of the regulation has been provided
for your convenience.
    Despite Mr. Olsen's contentions, the Administrator did not
review the grounds upon which Mr. Olsen relied in his petition
before refusing to accept his petition.  However, DEA has
recognized that the requirement that a petition be accepted for
filing absent some ambiguity or some defect in format was not met
in this matter.  Therefore, in the pending case before the Court
of Appeals, DEA has asked for a remand of the action in order
that the Administrator may accept Mr. Olsen's petition for filing
and review that petition on its merits.  The DEA is constrained
from commenting further on the merits of Mr. Olsen's case since
it is currently pending before the court of appeals.
    I hope the foregoing will assist you in responding to your
constituent.
    Sincerely,
    Stephen H. Greene
    Acting Administrator of Drug Enforcement

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

From: [e-mail] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: Olsen v. DEA (6 of 7)
Date: Sat, 27 Aug 1994 13:34:29
Message-ID: <[e-mail]>

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.
º 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-tetrahydrocan-nabinol (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. ºº 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, º 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, º 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. º
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. ºº 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. º
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]-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
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. º 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. º 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] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: Olsen v. DEA (7 of 7)
Date: Sat, 27 Aug 1994 13:36:34
Message-ID: <[e-mail]>

PRELIMINARY DRAFT OF PETITIONER'S RESPONSE
    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. ºº 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-tetrahydro-cannabinol (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 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;..."    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 agency's 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 Bonner's
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

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

From: [e-mail] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: OLSEN v. DEA, Legal Brief (1 of 2)
Date: Tue, 30 Aug 1994 21:33:29
Message-ID: <[e-mail]>

QUESTIONS PRESENTED FOR REVIEW
I.    Whether the Administrator of the Drug Enforcement
Administration erred in ruling that the final rule of May 13,
1986, placing synthetic dronabinol in sesame oil and encapsulated
in soft gelatin capsules in Schedule II did not included the
rescheduling of delta-9-tetrahydrocannabinol itself.
II.    Whether the Administrator of the Drug Enforcement
Administration erred in ruling that the final rule of May 13,
1986, placing synthetic dronabinol in sesame oil and encapsulated
in soft gelatin capsules in Schedule II did not included the
rescheduling of marijuana.
III.    Whether the Administrator of the Drug Enforcement
Administration erred procedurally by refusing to accept the
petition and ruling on its merit, simultaneously.
STATUTES AND REGULATIONS
    The pertinent statues and regulations are set forth in an
addendum bound with this brief.
JURISDICTION
    The final order of the Drug Enforcement Administration was
issued on October 23, 1992.  My Petition for Review was received
by this Court on November 12, 1992, and assigned Docket No. 92-
8041.  My Petition for Review was subsequently filed in forma
pauperis by this Court on February 8, 1993, and reassigned Docket
No. 93-1109 [App., p. 17].  This Court has jurisdiction of this
petition for review of a final order of the Drug Enforcement
Administration pursuant to 21 U.S.C. º 877.
STATEMENT OF THE CASE
    1.    THE CONTROLLED SUBSTANCES ACT.
    In 1970 Congress enacted the Controlled Substances Act
(CSA), a comprehensive statute designed to rationalize federal
control of dangerous drugs.  The Act contains five categories of
controlled substances, designated as Schedules I through V and
defined in terms of dangers and benefits.  21 U.S.C. º 812(b)(1)-
(5).  The control mechanisms imposed on manufacture, acquisition,
and distribution of substances listed under the Act vary
according to the schedule in which the substance is contained.
Substances in Schedules I & II are subject to the most severe
restrictions, and substances in Schedule V are subject to the
least severe restrictions.  In drafting the CSA Congress placed
marijuana in Schedule I, one of the two classifications that
provides for the most severe restrictions.
    Recognizing that the results of continuous research might
cast doubt on the wisdom of initial classification assignments,
Congress created a procedure by which changes in scheduling could
be effected.  Pursuant to Section 201(a) of the Act, 21 U.S.C. º
811(a), the Attorney General "may, by rule," add a substance to a
schedule, transfer it between schedules, or remove it from the
schedules.  A reclassification rule promulgated under this
section must be made on the record after opportunity for hearing,
in accordance with the rulemaking procedures prescribed by the
Administrative Procedure Act, 5 U.S.C. ch. 5, subch. II.  Section
201(a) further provides that rescheduling proceedings may be
initiated by the Attorney General on his [or her] own motion, at
the request of the Secretary of Health and Human Services (HHS),
or, as in the present case, on petition of any interested party.
    Section 501(a) of the CSA, 21 U.S.C. º 871(a), authorizes
the Attorney General to "delegate any of his functions under this
subchapter to any officer or employee of the Department of
Justice."  The functions vested in the Attorney General by the
CSA have been delegated to the Acting Administrator of the Drug
Enforcement Administration (DEA) pursuant to 28 C.F.R. ºº
0.100(b) & 0.132(d) (1992).
    DEA's Acting Administrator must share his [or her] decision-
making function under the Act with the Secretary of HHS.  Section
201(b), 21 U.S.C. º 811(b), provides that, prior to commencement
of reclassification rulemaking proceedings, the Attorney General
must "request from the Secretary a scientific and medical
evaluation, and his [or her] recommendations, as to whether such
drug or other substance should be so controlled or removed as a
controlled substance."  The evaluation prepared by the Secretary
must address the scientific and medical factors enumerated in
Section 201(c), 21 U.S.C. º 811(c); these factors relate to the
effects of the drug and its abuse potential.  Pursuant to Section
201(b), the Secretary's recommendations "shall be binding on the
Attorney General as to such scientific and medical matters, and
if the Secretary recommends that a drug or other substance not be
controlled, the Attorney General shall not control the drug or
other substance."
    Section 201(d) of the Act, 21 U.S.C. º 811(d), contains a
limited exception to the referral procedures detailed in Section
201(b)-(c).  Subsection (d)(1) provides:
    If control is required by United States obligations under
international treaties, conventions, or protocols in effect on
October 27, 1970, the Attorney General shall issue an order
controlling such drug under the schedule he [or she] deems most
appropriate to carry out such obligations, without regard to the
findings required by subsection (a) of this section or section
812(b) of this title and without regard to the procedures
prescribed by sections (a) and (b) of this section.
    2.    THE SINGLE CONVENTION ON NARCOTIC DRUGS.
    In 1948, in order to simplify existing treaties and
international administrative machinery, members of the United
Nations undertook codification of a single convention on
international narcotics control.  In 1961, after three
preliminary drafts, the Single Convention on Narcotic Drugs,
1961, 18 U.S.T. 1407 (1967), 520 U.N.T.S. 204 (1964), was opened
for signature.  The United States ratified the Single Convention
in 1967 -- three years prior to enactment of the CSA.
    Like the CSA, the Single Convention establishes several
classifications or "schedules" of substances, to which varying
regimes of control attach.  Schedule I of the Single Convention
contains substances considered to carry a relatively high abuse
liability; included in this category are heroin, methadone,
opium, coca leaf, and cocaine.  Schedule II and III contain those
substances regarded as less susceptible to abuse.  Finally,
Schedule IV of the Single Convention -- unlike CSA schedule IV --
embraces certain Schedule I substances, such as heroin, the abuse
liability of which is not offset by substantial therapeutic
advantages.  Marijuana (cannabis) is listed in Schedules I and IV
of the Single Convention, however, delta-9-tetrahydrocannabinol
(delta-9-THC) is not listed in the schedules of the Single
Convention.
    3.    THE CONVENTION ON PSYCHOTROPIC SUBSTANCES.
    In 1978 Congress enacted the Psychotropic Substances Act
(PSA), Pub. L. 95-633, Nov. 10, 1978, 92 Stat. 2768, to coincide
with the Convention on Psychotropic Substances, signed at Vienna,
Austria on February 21, 1971 [The Convention entered into force
in respect to the United States on July 15, 1980], 1019 U.N.T.S.
175 (1976), Treaty No. 14,596.  Section 101 of the PSA, 21 U.S.C.
º 801a, provides, in part:
    The United States has joined with other countries in
executing an international treaty, entitled the Convention on
Psychotropic Substances and signed at Vienna, Austria, on
February 21, 1971, which is designed to establish suitable
controls over the manufacture, distribution, transfer, and use of
certain psychotropic substances.
    The Convention on Psychotropic Substances contains four
categories of controlled substances, designated as Schedules I
through IV and defined in terms of dangers and benefits.  The
international control mechanisms imposed on manufacture,
acquisition, and distribution of substances listed under the
Convention on Psychotropic Substances vary according to the
schedule in which the substance is contained.  Substances in
Schedule I are subject to the most severe restrictions, and
substances in Schedule IV are subject to the least severe
restrictions.
    In drafting the Convention on Psychotropic Substances the
parties placed tetrahydrocannabinols in Schedule I, the
classification that provides for the most severe restrictions.
However, "At its 1,045th meeting, on April 29, 1991, the
Commission on Narcotic Drugs, in accordance with article 2,
paragraphs 5 and 6, of the Convention on Psychotropic Substances,
1971, decided, by a vote of 33 in favor and 5 against, with no
abstentions, that delta-9-tetrahydrocannabinol (also referred to
as delta-9-THC) and its stereochemical variants should be
transferred from Schedule I to Schedule II of that Convention."
Official Records of the Economic and Social Council, 1991,
Supplement No. 4 (E/1991/24, Supp. No. 4), pp. 23 and 98 [App.,
p. 10].  The five States voting against the decision were
Colombia, Ivory Coast, Egypt, France and Pakistan.  Id.
    4.    HISTORY OF THIS CASE.
    There are currently two other petitions for review, seeking
to have marijuana moved from Schedule I to Schedule II of the
CSA, now pending before this Court.  Alliance for Cannabis
Therapeutics v. Drug Enforcement Administration, No. 92-1168, and
Drug Policy Foundation v. Drug Enforcement Administration, No.
92-1179.  The Alliance for Cannabis Therapeutics (ACT) and the
Drug Policy Foundation (DPF) allege that marijuana has accepted
medical use in treatment in the United States, 21 U.S.C. º
812(b)(2)(B), and seek rescheduling on that basis.  They are
seeking review of a final order of the Drug Enforcement
Administration (DEA), issued on March 26, 1992, finding that
marijuana does not have accepted medical use in treatment in the
United States.  57 Fed. Reg. 10,499.
    The scheduling of marijuana under the Controlled Substances
Act (CSA), 21 U.S.C. º 812, as well as under international
obligations, has been under consideration by this Court on
several prior occasions.  NORML v. Ingersoll, 497 F.2d 654 (D.C.
Cir. 1974); NORML v. DEA, 559 F.2d 735 (D.C. Cir. 1977); and, ACT
v. DEA, 930 F.2d 936 (D.C. Cir. 1991).  The issue is still
pending before this Court in ACT v. DEA, No. 92-1168, and DPF v.
DEA, No. 92-1179.
    ACT and DPF inherited their case from NORML which filed a
petition to have marijuana removed from the CSA with the Bureau
of Narcotics and Dangerous Drugs (BNDD) on May 18, 1972.  The
BNDD refused to accept the petition for filing, and this Court
had to order the DEA to respond.  NORML v. Ingersoll, 497 F.2d
654 (D.C. Cir. 1974).  Upon remand the DEA held that
international treaty obligations required it to place marijuana
in Schedule I of the CSA.  This Court then remanded the petition
back to the DEA again, holding that marijuana can be placed in
either Schedule I or Schedule II of the CSA without violating
international treaty obligations, and requiring the DEA to hold
hearings to determine in which of the two schedules, Schedule I
or Schedule II, marijuana properly belongs.  NORML v. DEA, 559
F.2d 735, 757 (D.C. Cir. 1977).
    In the final order for which ACT and DPF seek review, the
Administrator listed five criteria for determining accepted
medical use, and found that marijuana failed to satisfy all five
criteria.  The Administrator said, "First, marijuana's chemistry
is neither fully known, nor reproducible."  57 Fed. Reg. at
10,507.  The Administrator went on to explain why marijuana
failed to satisfy the remaining four criteria, but these four
will not be repeated here, because failure to satisfy the first
criterion would almost certainly mean failure to satisfy the
remaining four.
    After reading the Administrator's final ruling of March 26,
1992, I sent a letter to the Administrator on July 21, 1992,
asking why coca and opium poppy plants are scheduled in Schedule
II of the CSA, since both of these plants are subject to the same
variances in chemistry as the marijuana plant (neither are
reproducible in standardized dosages) [App., p. 1].
    On August 17, 1992, the Administrator replied by stating
that "these plant materials [coca and opium poppy] have
historically been recognized as the source for a variety of
accepted and useful medications."  Letter from the Administrator,
dated August 17, 1992 [App., p. 5].  The Administrator also
stated that "the petition to reschedule marijuana did not involve
the scheduling of any medically useful compound to be extracted
from the plant material."  Id.
    Interpreting the Administrator's statements regarding
scheduling of coca and opium poppy plants and scheduling of a
medically useful compound extracted from marijuana as general
rules, I then filed my own Petition to Reschedule Marijuana based
on the fact that in 1986 dronabinol, delta-9-tetrahydrocannabinol
(delta-9-THC), the principle psychoactive substance in the
marijuana plant, was rescheduled to Schedule II of the Controlled
Substances Act, and, therefore, marijuana must be moved into the
same schedule as dronabinol [App., p. 2].  See Final Order of the
Drug Enforcement Administration, May 13, 1986, 51 Fed. Reg.
17,476 (placing dronabinol in Schedule II).
    My petition was filed on September 11, 1992, pursuant to 21
U.S.C. º 811 and 21 C.F.R. º 1307.03, in the form prescribed by
21 C.F.R. º 1308.44(b).
     The Administrator responded to my petition by stating, "In
a final rule published on May 13, 1986, then Administrator John
C. Lawn placed a very specific substance, synthetic dronabinol in
sesame oil and encapsulated in soft gelatin capsules, in Schedule
II.  Administrator Lawn's action did not involve the rescheduling
of delta-9-tetrahydrocannabinol itself, nor did it include any
form of dronabinol other than the synthetic."  Final rule of the
Administrator, October 23, 1992 [App., p. 7].
    The Administrator stated further, "Since I am not accepting
your petition on the grounds that dronabinol is a wholly
synthetic substance, not obtained from marijuana, it is
unnecessary for me to consider the broader question of whether
the rescheduling of marijuana would be appropriate if accepted
medications were indeed obtained from that source."  Id.

(continued in next message)

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

From: [e-mail] (Carl E. Olsen)
Newsgroups: talk.politics.drugs
Subject: OLSEN v. DEA, Legal Brief (2 of 2)
Date: Tue, 30 Aug 1994 21:36:34
Message-ID: <[e-mail]>

(continued from previous message)

SUMMARY OF ARGUMENT
    By definition, a synthetic drug is the same as its natural
occurring twin.  Delta-9-THC is only one substance, not two.  In
1986, Health and Human Services (HHS) recognized that synthetic
delta-9-THC is the same as its naturally occurring twin.  The DEA
must accept this scientific and medical findings of HHS.
    The DEA is trying to do something with delta-9-THC that it
doesn't do with any other drug, placing the synthetic drug in a
different schedule than its naturally occurring twin.  The DEA is
not authorized to make such distinctions.  The DEA must defer to
HHS for scientific and medical findings.
    Neither can the DEA rely on FDA marketing approval of
Marinol, synthetic dronabinol "in sesame oil and encapsulated in
soft gelatin capsules," as a reason for keeping all other forms
of delta-9-THC in Schedule I.  Sesame oil and gelatin capsules
are simply foods, which are not subject to control under the CSA.
It is delta-9-THC which is in Schedule II, not just the FDA
approved product Marinol.
    In 1986, when marijuana became the source of an accepted and
useful medication, delta-9-THC, it should have been transferred
into the same schedule of the CSA, Schedule II, as the other
plants, coca and opium, which are the sources of the accepted and
useful medications cocaine and morphine.
ARGUMENT
    1.    SYNTHETIC AND NATURAL DELTA-9-THC ARE THE SAME.
    The Administrator's decision that synthetic delta-9-THC in
sesame oil and encapsulated in soft gelatin capsules, but not
delta-9-THC itself, has been rescheduled, and that delta-9-THC is
not obtained from marijuana, is beyond the scope of the DEA's
authority.
    This Court must review the DEA's decision to schedule delta-
9-THC simultaneously in two different schedules in light of the
guidelines set forth by the Supreme Court in Chevron U.S.A., Inc.
v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104
S.Ct. 2778, 81 L.Ed.2d 694 (1984).  In Chevron, the Court
explained that a reviewing court must employ a two-step analysis
that focuses initially on the intentions of Congress:
First, always, is the question whether Congress had directly
spoken to the precise question at issue.  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.
Id. at 842-43, 104 S.Ct. at 2781 (emphasis supplied).  In the
absence of congressional intent, however, the court must proceed
to a second inquiry:
If ... the court determines Congress has not directly addressed
the precise question at issue, the court does not simply impose
its own construction on the statute, as would be necessary in the
absence of an administrative interpretation.  Rather, if the
statute is silent or ambiguous with respect to the specific
issue, the question for the court is whether the agency's answer
is based on a permissible construction of the statute.
Id. at 843, 104 S.Ct. at 2781-82 (footnote omitted; emphasis
supplied).
    In enacting the CSA, "Members of the House repeatedly stated
that the Department of Justice should make judgments based on law
enforcement considerations, while HEW should have the final say
with respect to medical and scientific determinations."  NORML v.
DEA, 559 F.2d at 746.  The Department of Justice "may not
schedule a substance under the CSA without first obtaining the
recommendation of the FDA, through its parent agency, HHS, 21
U.S.C. º 811(b), and providing an 'opportunity for a hearing
pursuant to rulemaking procedures prescribed by [the
Administrative Procedures Act].' 21 U.S.C. º 811(a)."  Grinspoon
v. DEA, 828 F.2d 881, 890 (1st Cir. 1987).  "This request is
filed with the Commissioner of FDA, who has the responsibility
for coordination of activities within [HHS]."  NORML v. DEA, 559
F.2d at 749 n.59.
    As this Court stated in 1977:
    Our interpretation of Section 201(d) ensures proper
allocation of decisionmaking responsibility between the Attorney
General and the Secretary of HEW, in accordance with their
respective spheres of expertise.  Section 201(d) directs the
Attorney General, as an initial matter, to make a legal judgment
as to controls necessitated by international commitments.  He
then establishes a minimum schedule or level of control below
which placement of the substance may not fall.  Determination of
a minimum schedule ensures that the Secretary's recommendation,
which ordinarily would be binding as to medical and scientific
findings, does not cause a substance to be scheduled in violation
of treaty obligations.  However, once that minimum schedule is
established by the Attorney General, the decision whether to
impose controls more restrictive than required by treaty
implicates the same medical and scientific considerations as do
scheduling decisions regarding those few substances not
controlled by treaty.  The Secretary of HEW is manifestly more
competent to make these nonlegal evaluations and recommendations.
NORML v. DEA, 559 F.2d at 747.
    Although the FDA has approved a New Drug Application (NDA)
for Marinol, synthetic delta-9-THC in sesame oil and encapsulated
in soft gelatin capsules, this does not qualify as a
recommendation to the DEA for purposes of scheduling.  FDA has
never recommended that delta-9-THC remain in Schedule I while
Marinol is in Schedule II, nor has it said that synthetic delta-
9-THC is better than delta-9-THC itself.  [App., p. 15]
    This is not the first time the DEA has tried to follow
verbatim text of FDA marketing approval for a New Drug
Application (NDA) in making a scheduling determination.  As this
Court stated in 1991:
The First Circuit in Grinspoon v. Drug Enforcement
Administration, 828 F.2d 881, 891-92 (1st Cir. 1987), upon which
petitioners rely, had held that earlier criteria the
Administrator had employed to define "currently accepted medical
use" were contrary to the statute because they were a carbon copy
of those used by the FDA in licensing new drugs.  The present
criteria, it is argued, duplicate a number of those original
criteria.  But the criteria challenged in Grinspoon included
several elements, such as the availability of patent information
or FDA-required labeling, which were necessary only to market the
drug in interstate commerce.  These criteria are clearly relevant
to the FDA's mission, but not the DEA's, see Grinspoon, 828 F.2d
at 887.  The First Circuit never suggested the DEA Administrator
was foreclosed from incorporating and relying on those standards
employed by the FDA that are relevant to the pharmaceutical
qualities of the drug.  The court merely held that while FDA
approval is sufficient to establish the existence of an accepted
medical use, the converse in not true -- that absent FDA
approval, commonly accepted medical use cannot be proven.  Id. at
890.  Nor can we conceive of a reason the Administrator should be
barred from employing notions developed by a sister agency
insofar as those notions serve the missions of both agencies.
ACT v. DEA, 930 F.2d at 939-40.
    In 1987, the First Circuit said,
[W]e find no necessary linkage between failure to obtain FDA
interstate marketing approval and a determination that the
substance in question is unsafe and has no medical use.  Indeed,
the FDCA does not even mention the term 'medical use.'  In short,
it is plainly possible that a substance may fail to obtain
interstate marketing approval even if it has an accepted medical
use.
Grinspoon, 828 F.2d at  887.  "Thus, it is possible that a
substance may have both an accepted medical use and safety for
use under medical supervision, even though no one has deemed it
necessary to seek approval for interstate marketing."  Id.
    A synthetic drug is the same as its naturally occurring
twin, by definition.  Under this Court's order of June 4, 1982,
in NORML v. DEA, No. 79-1660, the Department of Health and Human
Services (DHHS) was required to submit reports on the status of
its recommendations for the scheduling of THC and marijuana
plants.  In reference to the DEA's rescheduling order of May 13,
1986 (51 Fed. Reg. 17,476) the DHHS stated that, "Dronabinol is
structurally the same as THC."  [App., p. 8]
    The Administrator says that marijuana is not the source of
an accepted and useful medication, but there is considerable
evidence to the contrary.  In his final order on NORML's
petition, the Administrator adopted in their entirety the
findings of the former Administrator.  57 Fed. Reg. at 10,507.
The former Administrator, in his final order on NORML's petition,
stated, "There is no difference in the pharmacological effect
between the THC isolated from cannabis and the synthetically
produced THC which is now marketed in the United States."  54
Fed. Reg. at 53,774.  As this Court noted in 1991, "The First
Circuit never suggested the DEA Administrator was foreclosed from
incorporating and relying on those standards employed by the FDA
that are relevant to the pharmaceutical qualities of the drug."
ACT v. DEA, 930 F.2d at 939.  The former Administrator, in
agreement with HHS, recognized that the pharmaceutical qualities
of synthetic delta-9-THC are the same as those of delta-9-THC
itself.
    In his final order on NORML's petition, the Administrator
stated, "There are scientific studies showing pure THC (Delta-9-
Tetrahydrocannabinol), one of the many chemicals found in
marijuana, has some effect in controlling nausea and vomiting.
Pure THC is pharmaceutically made in clean capsule form, called
Marinol, and is available for use by the medical community.  More
information on Marinol can be found in the 'Physicians' Desk
Reference,' available in most libraries."  57 Fed. Reg. at
10,500.  The 1993 Physician's Desk Reference describes Marinol as
follows: "Dronabinol, commonly known as delta-9-THC, is one of
the major active substances in marijuana."  Id. at p. 2076.
    Synthetic delta-9-THC is an exact duplicate of its naturally
occurring twin, delta-9-THC.  "Following the isolation and
characterization of delta-9-THC as the major active component of
marijuana by Mechoulam and colleagues, a technique for producing
synthetic material was developed."  Plasse, T.; Gorter, R.;
Krasnow, S.; Lane, M.; Shepard, K.; Wadleigh, R. Recent Clinical
Experience With Dronabinol.  Pharmacology Biochemistry &
Behavior, Vol. 40, pp. 695-700; 1991 (Gaoni, Y.; Mechoulam, R.
The isolation and structure of 1-tetrahydrocannabinol and other
neutral cannabinoids from hashish. J. Am. Chem. Soc. 93:217-224;
1971)  (Petrzilka, T.; Haefliger, W.; Sikemeier, C. Synthesis of
hashish components. Part 4. Helv. Chim. Acta 52:1102-1134; 1969).
    In a letter dated July 13, 1993, the FDA states that, "A
synthetic drug ... is identical in all respects to the product
isolated from a plant source.  Such a product can be marketed
under the same name....  A synthetic drug would be in the same
schedule as its naturally occurring twin."  Letter from the FDA,
July 13, 1993 [App., p. 16].
    Clearly, delta-9-THC itself was approved for medical use by
the FDA when it approved Marinol.  "[T]he [DEA] does not have the
authority to impose Schedule I controls on a drug which has been
approved by the [FDA] for medical use."  Grinspoon, 828 F.2d at
890 (citing, 1984 U.S. Code Cong. & Admin. News 540, 543).
    When the Economic and Social Council of the United Nations
moved delta-9-THC from Schedule I to Schedule II of the
Convention on Psychotropic Substances, it made no distinction
between synthetic delta-9-THC and delta-9-THC itself.
    In 1986, then Administrator John C. Lawn improperly took
upon himself the authority to define synthetic delta-9-THC and
delta-9-THC itself as two separate substances under the CSA.
    In the course of rescheduling synthetic dronabinol to
Schedule II of the CSA, the original proposal submitted by the
DEA defined it as "the principle psychoactive substance in
Cannabis sativa L., marijuana," 50 Fed. Reg. 42,185 (October 18,
1985) (proposed rule), but this definition was changed to "the
synthetic equivalent of the isomer of delta-9-
tetrahydrocannabinol (THC) which is the principle psychoactive
substance in Cannabis sativa L., marijuana" in the final rule, 51
Fed. Reg. 17,476 (May 13, 1986) (final rule).  Whether this
change was accidental or intentional is hard to discern, but it
clearly exceeded the Administrator's authority.
    Although it is true that "[a]ppellate courts have neither
the expertise nor the resources to evaluate complex scientific
claims," this is not a complex scientific claim.  Grinspoon, 828
F.2d at 896 (citing, Thompson Medical Co. v. FTC, 791 F.2d 189,
196 (D.C. Cir. 1986)).  A synthetic drug must be the same as the
naturally occurring twin before it can receive FDA marketing
approval for distribution in interstate commerce.  As a matter of
law, delta-9-THC itself was rescheduled to Schedule II of the CSA
at the same time as synthetic delta-9-THC, and this Court should
so find.
    2.    MARIJUANA IS IN SAME SCHEDULE AS DELTA-9-THC.
    As this Court noted in 1991, "As is apparent, one salient
concept distinguishing the two schedules is whether a drug has
'no currently accepted medical use in treatment in the United
States.'"  ACT v. DEA, 930 F.2d at 938.  "However, placement in
Schedule I does not appear to flow inevitably from lack of
currently accepted medical use."  NORML v. DEA, 559 F.2d at 748.
"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."  Id.
    Moreover, DEA's own scheduling practices support the
conclusion that substances lacking medical usefulness need not
always be placed in Schedule I.  At the hearing before ALJ Parker
DEA's Chief Counsel, Donald Miller, testified that several
substances listed in CSA Schedule II, including poppy straw, have
no currently accepted medical use.  Tr. at 473-474, 488.  He
further acknowledged that marihuana could be rescheduled to
Schedule II without a currently accepted medical use.  Tr. at
487-488.  Neither party offered any contrary evidence.
Id.
    The explanation given by the Administrator for the placement
of coca and opium poppy plants in Schedule II is that coca and
opium poppy plants have been "recognized as the source for a
variety of accepted and useful medications."  Petition, Exhibit
A.  According to this explanation, marijuana should be
transferred to Schedule II, because it has now become the source
of an accepted and useful medication, after its initial placement
in Schedule I of the CSA in 1970.
    In the final order under review in this case, the
Administrator stated that, "Since I am not accepting your
petition on the grounds that dronabinol is a wholly synthetic
substance, not obtained from marijuana, it is unnecessary for me
to consider the broader question of whether the rescheduling of
marijuana would be appropriate if accepted medications were
indeed obtained from that source."  Final Order, October 23,
1992.
    Again, the standard of review is that of Chevron, 467 U.S.
837.  It is apparent from reading the CSA that Congress intended
to include coca and opium poppy plants in Schedule II because
useful medications were being derived from these plant sources
when the CSA was created in 1970.  The apparent distinction that
Congress made between marijuana and coca and opium poppy plants
when the schedules were created in 1970 was that coca and opium
poppy plants were the sources of useful and accepted medications,
while marijuana was not.  The Administrator has provided his
interpretation of the statute by stating "Congress was very much
aware that these plant materials [coca and opium poppy] have
historically been recognized as the source for a variety of
accepted and useful medications."  Petition, Exhibit A.
    The Administrator's interpretation reinforces what is
apparent from the face of the statute, that plants which are the
source of accepted and useful medications cannot be placed in a
schedule higher than Schedule II.  For example, peyote, a plant
which contains the Schedule I drug mescaline, is also in Schedule
I, while opium poppy, a plant which contains the Schedule II drug
morphine, is in Schedule II.
    To quote the Administrator, "Those who insist marijuana has
medical uses would serve society better by promoting or
sponsoring more legitimate scientific research, rather than
throwing their time, money and rhetoric into lobbying, public
relations campaigns and perennial litigation."  57 Fed. Reg. at
10,503.  Since marijuana belongs in Schedule II of the CSA, the
DEA should not even be involved in the debate on marijuana's
medical use.  Congress intended the FDA to handle this debate.
Scientific research will be promoted by treating marijuana
exactly the same as coca and opium poppy plants, the DEA will be
removed from the debate on marijuana's medical use, clearing the
way for the FDA to take over, and needless perennial litigation
will cease.
    Since accessibility for research purposes is exactly the
same under either Schedule I or Schedule II, there is no reason
for the DEA not to move marijuana into Schedule II, since DEA's
only legitimate concern under the CSA is drug diversion.
"Congress was particularly concerned with the diversion of drugs
from legitimate channels to illegitimate channels."  United
States v. Moore, 423 U.S. 122, 135 (1972).
    3.    THE PETITION MUST BE ACCEPTED BEFORE IT IS DENIED.
    Another question presented is whether the Administrator
followed proper procedure in refusing to accept the petition by
denying the petition on its merits.  Pursuant to 21 C.F.R. º
1308.44(c):
    Within a reasonable period of time after the receipt of a
petition, the Administrator shall notify the petitioner of his
acceptance or nonacceptance of the petition, and if not accepted,
the reason therefor.  The Administrator need not accept a
petition for filing if any of the requirements prescribed in
paragraph (b) of this section is lacking or is not set forth so
as to be readily understood.  If the petitioner desires, he may
amend the petition to meet the requirements of paragraph (b) of
this section.  If accepted for filing, a petition may be denied
by the Administrator within a reasonable period of time
thereafter if he finds the grounds upon which the petitioner
relies are not sufficient to justify the initiation of
proceedings.
The Administrator's streamlined procedure in this case appears to
be in conflict with DEA regulations.  This Court dealt with a
similar procedural question in 1974:
[T]he rejection of a filing is a "peremptory" response "which
classically is used not to dispose of a matter on the merits but
rather as a technique for calling on the filing party to put its
papers in proper form and order.  Its use is not limited to
defects of form.  It may be used by an agency where the filing is
so patently a nullity as a matter of substantive law, that
administrative efficiency and justice are furthered by obviating
any docket at the threshold rather than opening a futile docket."
146 U.S.App.D.C. at 299, 450 F.2d at 1346.
NORML v. Ingersoll, 497 F.2d at 659 n.10.  My petition was not
such a patent nullity, as matter of law, to justify either
refusal to accept the petition for filing, or denial of the
petition on its merits.  I was denied the opportunity to present
additional evidence to support my petition, and I am objecting to
this streamlined approach.
CONCLUSION
      Based on the foregoing, I respectfully request this Court to
rule that: (1) as a matter of law, delta-9-THC itself is in
Schedule II of the CSA; (2) as a matter of law, marijuana is in
Schedule II of the CSA; and (3) such other or further relief be
granted as this Court may deem necessary under the circumstances.
                        Respectfully submitted,
                        Carl Eric Olsen, pro se
                        Post Office Box 4091
                        Des Moines, Iowa 50333
                        [phone]
Dated: August 4, 1993

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