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_________________________________________________________________
_________________________________________________________________
CASE BEING CONSIDERED FOR TREATMENT
PURSUANT TO RULE 34(j) OF THE GENERAL RULES
IN THE UNITED STATES COURT OF APPEALS
FOR THE DISTRICT OF COLUMBIA CIRCUIT
______________________
No. 94-1605
______________________
CARL ERIC OLSEN,
Petitioner,
v.
DRUG ENFORCEMENT ADMINISTRATION,
Respondent.
______________________
PETITION FOR REVIEW OF AN ORDER OF THE
DRUG ENFORCEMENT ADMINISTRATION
______________________
BRIEF FOR THE RESPONDENT
______________________
JOHN C. KEENEY
Acting Assistant Attorney General
THERESA M.B. VAN VLIET
Chief
LENA WATKINS
JOHN J. FARLEY
Trial Attorneys
Narcotic and Dangerous Drug Section
Criminal Division
U.S. Department of Justice
P.O. Box 27312, Central Station
Washington, D.C. 20038
(202) 514-0917
OF COUNSEL:
DENNIS F. HOFFMAN
Drug Enforcement Administration
_________________________________________________________________
_________________________________________________________________
TABLE OF CONTENTS
PAGE
TABLE OF AUTHORITIES . . . . . . . . . . . . . . . . . . . . ii
CERTIFICATE AS TO PARTIES, RULINGS, AND RELATED CASES . . . . v
GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . vi
STATEMENT OF THE ISSUE . . . . . . . . . . . . . . . . . . . 1
STATUTES AND REGULATIONS . . . . . . . . . . . . . . . . . . 1
STATEMENT OF THE CASE . . . . . . . . . . . . . . . . . . . . 2
I. STATUTORY AND REGULATORY BACKGROUND . . . . . . . . 2
II. THE CURRENT PROCEEDINGS . . . . . . . . . . . . . . 5
SUMMARY OF THE ARGUMENT . . . . . . . . . . . . . . . . . . . 8
ARGUMENT . . . . . . . . . . . . . . . . . . . . . . . . . . 9
I. STANDARD OF REVIEW . . . . . . . . . . . . . . . . 9
II. CONGRESS, DEA, AND THE COURTS HAVE ALL FOUND THAT
MARIHUANA IS PROPERLY IN SCHEDULE I OF THE CSA AND
MUST REMAIN THERE UNTIL IT SATISFIES THE CRITERIA
IN 21 U.S.C. 812(b). . . . . . . . . . . . . . . . 10
III. DEA PROPERLY FOUND THAT THE PETITION WAS NOT
SUFFICIENT TO JUSTIFY ADDITIONAL RESCHEDULING
PROCEEDINGS BECAUSE THE PETITION WAS PREMISED ON
THE INCORRECT BELIEF THAT A SCHEDULE I DRUG MUST
BE RESCHEDULED IF IT IS THE SOURCE OF AN ACCEPTED
AND USEFUL MEDICATION. . . . . . . . . . . . . . . 13
A. THE PETITIONER'S ARGUMENT . . . . . . . . . . 13
B. THE CSA DOES NOT MANDATE THAT A SCHEDULE I
DRUG MUST BE RESCHEDULED IF IT IS THE SOURCE
OF AN ACCEPTED AND USEFUL MEDICATION BUT
REQUIRES DEA TO MAKE INDIVIDUAL FINDINGS
ABOUT A PARTICULAR DRUG PRIOR TO RESCHEDULING
IT. . . . . . . . . . . . . . . . . . . . . . 14
IV. THE ADMINISTRATOR PROPERLY DENIED THE PETITION
BECAUSE IT RELIED ON THE INCORRECT ASSUMPTION THAT
DRONABINOL HAS BEEN MOVED TO SCHEDULE II WHEN IN
FACT ONLY A SINGLE PHARMACEUTICAL PRODUCT HAS BEEN
MOVED TO SCHEDULE II. . . . . . . . . . . . . . . . 19
CONCLUSION . . . . . . . . . . . . . . . . . . . . . . . . . 23
ii
TABLE OF AUTHORITIES
CASES PAGE
Alliance for Cannabis Therapeutics v. Drug Enforcement
Administration, 15 F.3d 1131 (D.C. Cir. 1994) . 3,16,18,19*
Alliance for Cannabis Therapeutics v. Drug Enforcement
Administration, 930 F.2d 936 (D.C. Cir. 1991) . . . . 2,3,16*
Chevron U.S.A., Inc. v. Natural Resources Defense Council,
Inc., 467 U.S. 837 (1984) . . . . . . . . . . . . 10,16,17
Cutler v. Hayes, 818 F.2d 879 (D.C. Cir. 1987) . . . . . . 21,22
Fertilizer Institute v. United States Environmental
Protection Agency, 935 F.2d 1303 (D.C. Cir. 1991) . . . . 22
Grinspoon v. Drug Enforcement Admin., 828 F.2d 881
(lst Cir. 1987) . . . . . . . . . . . . . . . . . . . . 21
Independent Insurance Agents of America, Inc. v. Ludwig,
997 F.2d 958 (D.C. Cir. 1993) . . . . . . . . . . . . . 18
National Organization for the Reform of Marijuana Laws v.
Bell, 488 F. Supp. 123 (D.D.C. 1980) . . . . . 12,14,16,19*
National organization for the Reform of Marijuana Laws v.
Drug Enforcement Admin., 559 F.2d 735 (D.C. Cir. 1977) . 3,16
National Organization for the Reform of Marijuana Laws v.
Ingersoll, 497 F.2d 654 (D.C. Cir. 1974) . . . . . . . . . 3
Olsen v. Drug Enforcement Admin., 776 F.2d 267 (llth Cir.
1985), cert. denied, 475 U.S. 1030 (1986) . . . . . . . . 7
Olsen v. Iowa, 808 F.2d 652 (8th Cir. 1986) . . . . . . . . . . 6
Olsen v. State, Civ. No. 83-301-E, 1986 WL 4045 (S.D. Iowa
March 19, 1986) . . . . . . . . . . . . . . . . . . . . . 6
Randolph-Sheppard Vendors of America v. Weinberger, 795 F.2d
90 (D.C. Cir. 1986) . . . . . . . . . . . . . . . . . 21-22
State v. Olsen, 315 N.W.2d 1 (Iowa 1982) . . . . . . . . . . . 6
USAA Federal Savings Bank v. McLaughlin, 849 F.2d 1505
(D.C. Cir. 1988) . . . . . . . . . . . . . . . . . . . . 18
____________________
* Authorities chiefly relied upon.
iii
United States v. Fogarty, 692 F.2d 542 (8th Cir. 1982),
cert. denied, 460 U.S. 1040 (1983) . . . . . . . . . . 12,16
United States v. Greene, 892 F.2d 453 (6th Cir. 1989), cert.
denied, 495 U.S. 935 (1990) . . . . . . . . . . . . . . 12
United States v. Middleton, 690 F.2d 820 (11th Cir. 1982),
cert. denied, 460 U.S. 1051 (1983) . . . . . . . . . . . 12
United States v. Rush, 738 F.2d 497 (lst Cir. 1984), cert.
denied, 470 U.S. 1004 (1985) . . . . . . . . . . . . . . . 6
United States v. Walton, 514 F.2d 201 (D.C. Cir. 1975) . . . 15
United States v. Whitley, 734 F.2d 1129 (6th Cir. 1984) . . . 18
REGULATIONS
21 C.F.R.:
1307.03 . . . . . . . . . . . . . . . . . . . . . . . . . 6
1308.11 . . . . . . . . . . . . . . . . . . . . . 16-17,20
1308.12 . . . . . . . . . . . . . . . . . . . . . . . . 20
1308.44 . . . . . . . . . . . . . . . . . . . . . . . 9-10
28 C.F.R.:
0.100(b) . . . . . . . . . . . . . . . . . . . . . . . . . 3
0.104 . . . . . . . . . . . . . . . . . . . . . . . . . . 3
50 Fed. Reg. 42,186 . . . . . . . . . . . . . . . . . . . . 19,21
51 Fed. Reg. 17,476 . . . . . . . . . . . . . . . . . . . 20,21*
51 Fed. Reg. 22,946 . . . . . . . . . . . . . . . . . . . . . . 3
54 Fed. Reg. 53,767 . . . . . . . . . . . . . . . . . . . 3,6,16*
57 Fed. Reg. 10,499 . . . . . . . . . . . . . . . . . 3,4,16,20*
58 Fed. Reg. 25,790 . . . . . . . . . . . . . . . . . . . . . 16
STATUTES
5 U.S.C.:
706 . . . . . . . . . . . . . . . . . . . . . . . . . 10,26
21 U.S.C.:
811 . . . . . . . . . . . . . . . . . . . . 2,6,9,10,12,15*
812 . . . . . . . . . . . . . . . . . . . 2,4,10,14-17,21*
877 . . . . . . . . . . . . . . . . . . . . . . . . . 8,10
____________________
* Authorities chiefly relied upon.
iv
MISCELLANEOUS
H. Rep. No. 1444, 81st Cong., 2nd Sess., reprinted in 1970
U.S.C.C.A.N. 4566 . . . . . . . . . . . . . . . . . . . . 11-12
v
CERTIFICATE AS TO PARTIES, RULINGS, AND RELATED CASES
A. Parties and Amici
All parties, intervenors, and amici appearing before the
agency and in this court are listed in the Petitioner's Brief.
B. Rulings Under Review
References to the ruling at issue appear in the Petitioner's
Brief. The ruling is reproduced on pages 17-25 of the
Petitioner's Appendix.
C. Related Cases
This matter was previously before this court in Olsen v.
Drug Enforcement Admin., No. 93-1109 (D.C. Cir. Dec. 9, 1993).
In that case, the court granted DEA's motion for remand.
References to related cases in the Petitioner's Brief
accurately identify cases before this court that previously
addressed the scheduling of marihuana. Another case addressing
the scheduling of marihuana is National Org. for the Reform of
Marijuana Laws v. Bell, 488 F. Supp. 123 (D.D.C. 1980) (three
judge court).
vi
GLOSSARY
CSA - Controlled Substances Act, 21 U.S.C. 801 et seq.
DEA - U.S. Drug Enforcement Administration
FDA - U.S. Food and Drug Administration
HEW - U.S. Department of Health, Education, and Welfare
THC - tetrahydrocannabinol
vii
CASE BEING CONSIDERED FOR TREATMENT
PURSUANT TO RULE 34(j) OF THE GENERAL RULES
IN THE UNITED STATES COURT OF APPEALS
FOR THE DISTRICT OF COLUMBIA CIRCUIT
______________________
No. 94-1605
______________________
CARL ERIC OLSEN,
Petitioner,
v.
DRUG ENFORCEMENT ADMINISTRATION,
Respondent.
______________________
PETITION FOR REVIEW OF AN ORDER OF THE
DRUG ENFORCEMENT ADMINISTRATION
______________________
BRIEF FOR THE RESPONDENT
______________________
STATEMENT OF THE ISSUE
Whether the Drug Enforcement Administration properly
rejected the petitioner's theory that marihuana plants should be
moved from Schedule I to Schedule II of the Controlled Substances
Act because marihuana plants are a source of an accepted and
useful medication when the petitioner's theory was based solely
upon language in an informal letter and was contradicted directly
by the plain language of the Controlled Substances Act.
STATUTES AND REGULATIONS
Except for those already included in the Addendum to the
Petitioner's Brief, the pertinent statutes and regulations are
set forth in an addendum bound with this brief.
1
STATEMENT OF THE CASE
I. STATUTORY AND REGULATORY BACKGROUND
In response to the growing drug problem in the United
States, Congress in 1970 passed the Controlled Substances Act, 21
U.S.C. 801 et seq. ("CSA"). The CSA classifies various hazardous
drugs into five schedules. Id. 812. Restrictions upon use and
access to a particular drug vary based upon the drug's schedule
status in the CSA. Drugs in Schedule I are subject to more
severe restrictions than drugs in the other schedules. See
Alliance for Cannabis Therapeutics v. Drug Enforcement Admin.,
930 F.2d 936, 937 (D.C. Cir. 1991). Congress placed marihuana in
Schedule I of the CSA.1 21 U.S.C. 812(c), Schedule I(c)(10).
Although Congress made the initial scheduling decisions, the
CSA specifically permits the Attorney General to add a substance
to a schedule, transfer a substance from one schedule to another
or remove a substance from the schedules entirely. Id. 811(a).
The Attorney General may only transfer a substance to a different
schedule if she "finds that such drug or other substance has a
potential for abuse" and makes findings that the drug or
substance meets the requirements for the new schedule. Id. The
findings required for placing a substance in a particular
schedule are listed in 21 U.S.C. 812(b). The Attorney General
has delegated the authority to reschedule controlled substances
____________________
1 The substance is called "marihuana" in the CSA and the
respondent will use that spelling throughout this brief.
However, where the spelling "marijuana" is used in a quoted
passage, the spelling has not been changed.
2
to the Administrator of the Drug Enforcement Administration
("DEA"). 28 C.F.R. 0.100(b). The Drug Enforcement Administrator
("Administrator") has further delegated this authority to the
Deputy Administrator. 28 C.F.R. 0.104.
For over 20 years, various groups and individuals have asked
DEA to exercise its authority to move marihuana from Schedule I
to a less restrictive schedule or to remove marihuana from the
CSA schedules entirely. See Alliance for Cannabis Therapeutics
v. Drug Enforcement Admin., 15 F.3d 1131 (D.C. Cir. 1994);
Alliance for Cannabis Therapeutics, 930 F.2d at 937; National
Org. for the Reform of Marijuana Laws v. Drug Enforcement Admin.,
559 F.2d 735 (D.C. Cir. 1977); National Org. for the Reform of
Marijuana Laws v. Ingersoll, 497 F.2d 654 (D.C. Cir. 1974).
Despite these efforts, in March of 1992, the Administrator issued
a final order denying a petition to reschedule marihuana from
Schedule I to Schedule II of the CSA. See 57 Fed. Reg. 10,499
(1992).2
The Administrator relied upon the language of the CSA in
____________________
2 DEA's review of the rescheduling petition was quite
extensive. DEA issued a notice of a hearing on the rescheduling
petition in 1986. See 51 Fed. Reg. 22,946 (1986). After
hearings before an administrative law judge, the Administrator
issued findings of fact and conclusions of law that determined
that marihuana should not be moved from Schedule I because the
marihuana plant has no currently accepted medical use and because
it is not safe for use, even under medical supervision. See 54
Fed. Reg. 53,767, 53,784 (1989). On appeal, this court generally
upheld the Administrator's decision but remanded the matter for
clarification. See Alliance for Cannabis Therapeutics, 930 F.2d
at 940-941. On remand, the Administrator again found that
marihuana plants should remain in Schedule I. See 57 Fed. Reg.
at 10,507-10,508. The latter decision was affirmed by this Court
in Alliance for Cannabis Therapeutics, 15 F.3d at 1137.
3
making his determination. Under the CSA, a drug or substance may
not be placed in Schedule II absent findings 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 substances may
lead to severe psychological or physical
dependence.
21 U.S.C. 812(b)(2)(A)-(C).
In the Administrator's final order, he concluded that the
marihuana plant had no currently accepted medical use and thus
could not be placed in schedule II. 57 Fed. Reg. at 10,499.
The Administrator applied a five-part test for determining
whether a substance had a currently accepted medical use:
(1) the drug's chemistry must be known and reproducible;
(2) there must be adequate safety studies;
(3) there must be adequate and well-controlled
studies proving efficacy;
(4) the drug must be accepted by qualified experts; and
(5) the scientific evidence must be widely available.
57 Fed. Reg. at 10,504-10,507. After reviewing the evidence in
the record, the Administrator found that marihuana could not
satisfy a single one of these criteria. Id. at 10,507. These
findings, as well as other findings of fact and conclusions of
law, resulted in the denial of the marihuana rescheduling
petition.
4
II. THE CURRENT PROCEEDINGS
On July 21, 1992, the petitioner sent a letter to then-
Administrator Robert C. Bonner in which he raised several
questions about the Administrator's final order. In the letter,
the petitioner appeared to agree with the Administrator's finding
that marihuana, as a plant, failed to satisfy the first part of
the test for determining a currently accepted medical use because
a plant such as marihuana is not a scientifically established
compound capable of reproduction in standard dosages. A. 1.3
The petitioner's letter then asked why coca and opium plants (the
sources of cocaine, morphine, and heroin) were placed in Schedule
II. Id. If, the petitioner reasoned, coca and opium plants are
subject to the same scientific variances as marihuana plants,
then DEA is "treating marijuana unfairly." Id. The petitioner
suggested either removing all plants from the CSA schedules
because they "will never fit into your definition of drugs" or
changing the definition to account for the inconsistency in the
treatment of the different plants. Id.
On August 17, 1992, Administrator Bonner sent the petitioner
a response to his letter. A. 5. In the response, the
Administrator rejected the petitioner's attempt to analogize
marihuana plants to coca and opium plants. Id. The
Administrator explained that when Congress placed coca leaves and
opium plant materials in Schedule II, it was aware that these
____________________
3 "A." references are to the bound appendix submitted by
the petitioner with his brief.
5
plants had been recognized historically as the source for a
variety of accepted and useful medications. Id. The plants
contain medically active alkaloids that can be extracted and used
to produce pharmaceutical compounds capable of reproduction in
standardized doses. Id. In contrast, the Administrator pointed
out that the recent attempts to reschedule marihuana were not
grounded on claims that medically useful compounds could be
extracted from marihuana, but rather that smoking marihuana
itself produced medical benefits. Id. Thus, the Administrator
found the scheduling decisions to be reconcilable. Id. at 5-6.
The petitioner, proceeding t)ro se, then filed a formal
request for the rescheduling of marihuana pursuant to 21 U.S.C.
811 and 21 C.F.R. 1307.03.4 A. 2-4. In his petition, he drew
an analogy from language in the Administrator's letter of August
17, 1992. He reasoned that if coca leaves and opium plants could
be placed in Schedule II because they are sources of accepted and
____________________
4 The petitioner has frequently litigated issues related
to the legal treatment of marihana. He challenged several
criminal convictions by arguing that marihuana smoking was
protected by the free exercise clause of the First Amendment and
the equal protection clause of the Fourteenth Amendment. See
Olsen v. Iowa, 808 F.2d 652, 653 (8th Cir. 1986); United States
v. Rush, 738 F.2d 497, 511-513 (lst Cir. 1984), cert. denied, 470
U.S. 1004 (1985); State v. Olsen, 315 N.W.2d 1, 7-9 (Iowa 1982).
Additionally, the petitioner has brought numerous civil actions
seeking to obtain judicial authorization to use marihuana. See
Olsen v. Drug Enforcement Admin., 878 F.2d 1458, 1461-1465 (D.C.
Cir. 1989), cert. denied, 495 U.S. 906 (1990); Olsen v. Drug
Enforcement Admin., 776 F.2d 267, 268 (llth Cir. 1985), cert.
denied, 475 U.S. 1030 (1986); Olsen v. State, Civ. No. 83-301-E,
1986 WL 4045, at *1 (S.D. Iowa March 19, 1986). The petitioner
also participated in the administrative proceedings where the DEA
considered a petition to reschedule marihuana from Schedule I to
Schedule II of the CSA. See 54 Fed. Reg. at 53,767.
6
useful medications, then marihuana plants could be placed in
schedule II if marihuana is shown to be "a source for an accepted
and useful medication." A. 3. The petitioner then noted that
dronabinol, a synthetic equivalent of the isomer which is the
principle psychoactive substance in marihuana, has been
rescheduled to Schedule II. Id. Because marihuana is the source
of an accepted and useful medication, dronabinol, the petitioner
reasoned that marihuana must be moved to Schedule II of the CSA.
Id. at 4. The petitioner then requested that the Administrator
reschedule marihuana from Schedule I to Schedule II of the CSA.
Id. at 2.5
The Administrator initially refused to accept the
rescheduling petition because dronabinol is a wholly synthetic
substance and is not obtained from marihuana. A. 7. However,
after the petitioner appealed, DEA voluntarily asked this court
to remand the petition for a ruling. This court remanded the
petition in an Order dated December 9, 1993. See Olsen v. Drug
Enforcement Admin., No. 93-1109 (D.C. Cir. Dec. 9, 1993).
On May 16, 1994, Deputy Administrator Stephen H. Greene
issued a nine-page final order denying the petition. A. 17. The
final order explained that Congress placed marihuana in Schedule
I. A. 19-20. It rejected the petitioner's analogy, finding that
marihuana can only be moved from Schedule I if there is a finding
that marihuana has a "currently accepted medical use in treatment
____________________
5 The petitioner did not ask DEA to reschedule any other
substances.
7
in the United States." A. 22. The order acknowledged that (-)
delta-9-trans-THC isomer, the principal psychoactive ingredient
in marihuana, is also the ingredient in a pharmaceutical product
that has proven to be a safe and effective anti-emetic for
patients receiving cancer chemotherapy. Id. However, the order
noted that only a very specific synthetic dronabinol product was
rescheduled to Schedule II -- "dronabinol ("synthetic) in sesame
oil and encapsulated in a soft gelatin capsule" in a drug product
approved by the Food and Drug Administration ("FDA"). A. 23.
The order further stated that the regulation of plants and
chemicals under the CSA is distinct and that the CSA requires the
independent evaluation of each individual controlled substance.
A. 24. The final order reaffirmed that marihuana plants have no
currently accepted medical use in treatment and found that the
rescheduling of one pharmaceutical product did not require DEA to
transfer marihuana plants or any other substance to Schedule II.
A. 24-25.
The petitioner has appealed the final order to this court
pursuant to 21 U.S.C. 877.
SUMMARY OF THE ARGUMENT
Congress placed marihuana in Schedule I of the CSA and this
decision has been consistently approved by the courts. The
petitioner is incorrect in asserting that marihuana must be moved
from Schedule I to Schedule II if it is a source of an accepted
and useful medication. The plain language of the CSA requires
that a substance itself must have a currently accepted medical
8
use before it may be moved from Schedule I to Schedule II. The
petitioner has failed to provide any evidence to suggest that the
marihuana plant itself has a currently accepted medical use.
Under the CSA, the rescheduling of synthetic dronabinol in a
pharmaceutical product has no effect on the scheduling of the
marihuana plant. Thus, the petitioner's request for rescheduling
failed to raise any issue that justified the initiation of
rescheduling proceedings.
The petitioner is also incorrect in asserting that
dronabinol was moved from Schedule I to Schedule II. Only one
specific pharmaceutical product containing synthetic dronabinol
has been moved to Schedule II: synthetic dronabinol in sesame oil
and encapsulated in a soft gelatin capsule in a FDA-approved drug
product. Although the petitioner now seeks to challenge the
legality of the rule rescheduling this pharmaceutical product and
argues that dronabinol should have been rescheduled in its
entirety, he did not raise these issues before DEA. These
issues should not be considered for the first time by this court.
ARGUMENT
I. STANDARD OF REVIEW
Any interested person may submit a petition to DEA
requesting that DEA reschedule a controlled substance. 21 U.S.C.
811(a); 21 C.F.R. 1308.44(a). However, a petition that is
accepted for filing "may be denied by the Administrator within a
reasonable time thereafter if he finds the grounds upon which the
petitioner relies are not sufficient to justify the initiation of
9
proceedings." 21 C.F.R. 1308.44(c). The Administrator relied
upon this provision in denying the petition in the instant case.
A. 18-19.
In reviewing the Administrator's decision, findings of fact,
"if supported by substantial evidence, shall be conclusive." 21
U.S.C. 877. Additionally, DEA's action may be set aside if it
was arbitrary, capricious, an abuse of discretion or contrary to
law. 5 U.S.C. 706. However, when reviewing an administrative
agency's interpretation of a statute, the court must give effect
to the unambiguously expressed intent of Congress. Chevron
U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S.
837, 842-843 (1984). If the statute is silent or ambiguous, the
court is to determine whether the agency's interpretation is
based upon a permissible construction of the statute. Id. at
843. The court may not substitute its own judgment for a
reasonable interpretation made by the administrator of an agency.
Id. at 844.
II. CONGRESS, DEA, AND THE COURTS HAVE ALL FOUND THAT
MARIHUANA IS PROPERLY IN SCHEDULE I OF THE CSA AND MUST
REMAIN THERE UNTIL IT SATISFIES THE CRITERIA IN 21
U.S.C. 812(b).
Congress made the initial decision to place marihuana in
Schedule I. 21 U.S.C. 811(c). This decision was made after
careful consideration. The legislative history of the CSA
demonstrates that Congress was sensitive to the arguments of
10
those who advocated the deregulation of marihuana.6 See H. Rep.
No. 1444, 81st Cong., 2d Sess. 12-13, reprinted in 1970
U.S.C.C.A.N. 4566, 4577-4578. Congress also sought the advice of
the Department of Health, Education, and Welfare ("HEW") before
making a scheduling determination for marihuana.7 After
considering this information, Congress placed marihuana in
Schedule I so that the drug would be subject to the CSA's "most
stringent controls." Id. at 14, reprinted in 1970 U.S.C.C.A.N.
____________________
6 The House Report on the CSA contains several pages of
discussion about the proper treatment of marihuana under the CSA.
The House Report noted that:
The extent to which marihuana should be controlled is a
subject upon which opinions diverge widely. There are
some who not only advocate its legalization but would
encourage its use; at the other extreme there are some
States which have established the death penalty for
distribution of marihuana to minors.
H. Rep. No. 1444, 81st Cong., 2d Sess. 12, reprinted in 1970
U.S.C.C.A.N. 4566, 4577.
7 The Assistant Secretary for Health and scientific
Affairs wrote to Chairman Harley 0. Staggers that:
Some question has been raised whether the use of the
plant itself produces "severe psychological or physical
dependence" as required by a schedule I or even
schedule II criterion. Since there is still a
considerable void in our knowledge of the plant and
effects of the active drug contained in it, our
recommendation is that marihuana be retained within
schedule I at least until the completion of certain
studies now underway to resolve this issue. If those
studies make it appropriate for the Attorney General to
change the placement of marihuana to a different
schedule, he may do so in accordance with the authority
provided under section 201 of the bill.
Letter from Dr. Roger 0. Egeberg, Assistant Secretary for Health
and Scientific Affairs, Dep't of HEW, to Hon. Harley 0. Staggers,
Chairman, House Comm. on Interstate and Foreign Commerce,
reprinted in id. at 61, reprinted in 1970 U.S.C.C.A.N. at 4629.
11
at 4579.
Since the passage of the CSA, numerous individuals have
attempted to challenge the decision of Congress to place
marihuana in Schedule I as being irrational or unconstitutional.
These challenges have been uniformly rejected by the federal
courts. See, e.g., United States v. Greene, 892 F.2d 453, 455-
456 (6th Cir. 1989), cert. denied, 495 U.S. 935 (1990); United
States v. Fogarty, 692 F.2d 542, 547 (8th Cir. 1982), cert.
denied, 460 U.S. 1040 (1983); United States v. Middleton, 690
F.2d 820, 823 (11th Cir. 1982), cert. denied, 460 U.S. 1051
(1983); National Org. for the Reform of Mariiuana Laws v. Bell,
488 F. Supp. 123, 139-141 (D.D.C. 1980) (three judge court).
In rejecting constitutional challenges to the initial
classification of marihuana, courts frequently have pointed out
that 21 U.S.C. 811(a) provides the Attorney General with the
authority to reclassify marihuana if scientific information later
demonstrates that Schedule I is not the appropriate schedule.
See, e.g., Greene, 892 F.2d at 456; Fogarty, 692 F.2d at 548;
Middleton, 690 F.2d at 823; National Org. for the Reform of
Mariiuana Laws, 488 F. Supp. at 141. DEA, on behalf of the
Attorney General, recently conducted lengthy proceedings pursuant
to 811(a) and found that marihuana should not be moved from
Schedule I because the plant has no currently accepted medical
use and because it is not safe for use, even under medical
supervision. These decisions were approved by this court. See
footnote 2, supra.
12
III. DEA PROPERLY FOUND THAT THE PETITION WAS NOT SUFFICIENT
TO JUSTIFY ADDITIONAL RESCHEDULING PROCEEDINGS BECAUSE THE
PETITION WAS PREMISED ON THE INCORRECT BELIEF THAT A
SCHEDULE I DRUG MUST BE RESCHEDULED IF IT IS THE SOURCE OF
AN ACCEPTED AND USEFUL MEDICATION.
In seeking to reschedule marihuana from Schedule I to
Schedule II, the petitioner made a rather creative argument based
upon several flawed premises. DEA properly detected the flaws in
the petitioner's logic and found that the petition raised no
credible issue that would justify additional proceedings to
reschedule marihuana.
A. THE PETITIONER'S ARGUMENT
The petitioner's argument was based entirely upon his
construction of language contained in then-Administrator Bonner's
response to an earlier letter sent by the petitioner. In
response to the petitioner's query about why marihuana plants are
in Schedule I while coca leaves and opium plants are in Schedule
II, the Administrator stated that:
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.
A. 5. The petitioner then seized upon the Administrator's
language as "general rules of statutory construction." Pet. Br.
9. Using the newly created rules of statutory construction as
his springboard, the petitioner took an additional logical leap
by inferring that if marihuana were found to be a "source for an
accepted and useful medication," it must be moved from Schedule I
to Schedule II. A. 3-4.
13
Having created a new theory of statutory construction, the
petitioner proceeded to apply it with apparently successful
results. He noted that a synthetic equivalent of the principal
psychoactive ingredient in marihuana recently had been moved from
Schedule I to Schedule II. Since marihuana was the source of
this "accepted and useful medication," the petitioner concluded
that marihuana "must now be moved from Schedule I to Schedule II
of the CSA." A. 4.
B. THE CSA DOES NOT MANDATE THAT A SCHEDULE I
DRUG MUST BE RESCHEDULED IF IT IS THE SOURCE
OF AN ACCEPTED AND USEFUL MEDICATION BUT
REQUIRES DEA TO MAKE INDIVIDUAL FINDINGS
ABOUT A PARTICULAR DRUG PRIOR TO RESCHEDULING
IT.
The premise of the petitioner's argument is that if a
Schedule I controlled substance is the source of an accepted and
useful medication, the Schedule I substance must be placed into
the schedule that contains the accepted and usef ul medication.
This premise is in direct conflict with the language of the CSA.
As discussed previously, Congress itself decided to place
marihuana in Schedule I. See National Org. for the Reform of
Mariiuana Laws, 488 F. Supp. at 141. Although marihuana may be
rescheduled:
[t]he clear meaning of section 812(c) is that Congress
intended marijuana to remain in Schedule I until such
time as it might be reclassified by the Attorney
General on the basis of more complete scientific
information about the drug. In such a reclassification
hearing, the statutory criteria would be the guides to
determining the most appropriate schedule for
marijuana.
Id. Thus, under the CSA, marihuana plants should remain in
14
Schedule I unless and until more complete information indicates
that placement in a different schedule is more appropriate.
The CSA's language concerning the rescheduling of a
controlled substance does not suggest that a substance should be
rescheduled merely because it is the source for an accepted and
useful medication. The CSA states that in order to transfer a
controlled substance from one schedule to another, the Attorney
General must make "with respect to such druct or other substance
the findings prescribed by" 21 U.S.C. 812(b) "for the schedule in
which such drug is to be placed." 21 U.S.C. 811(a)(1)(B)
(emphasis added). Under 812(b), "a drug or other substance may
not be placed in any schedule unless the findings required for
such schedule are made with respect to such drug or other
substance." 21 U.S.C. 812(b) (emphasis added). Thus, contrary
to the petitioner's representations, the plain language of the
CSA states that in order for DEA to reschedule marihuana plants
from Schedule I to Schedule II, DEA must make the appropriate
findings with respect to marihuana plants.8
The CSA states that DEA cannot move a drug from Schedule I
to Schedule II unless it finds, inter alia, that the "drug or
other substance" to be rescheduled has a currently accepted
____________________
8Thus, the Deputy Administrator was correct in stating that
"[w]hether or not marijuana is a source of delta-9-THC is
irrelevant to the status of marijuana under the CSA." A. 20.
Despite the petitioner's assertions, this statement is not
inconsistent with United States v. Walton, 514 F.2d 201 (D.C.
Cir. 1975). The statement simply indicates that each drug is
evaluated under 21 U.S.C. 812(b) based upon an independent
assessment of its features, not based upon other possible uses of
the chemicals contained within the drug.
15
medical use.9 21 U.S.C. 812(b)(2)(B). The CSA's language does
not state or imply that this criterion can be satisfied by a
substance that is the source of a drug with a currently accepted
medical use. Additionally, the petitioner has produced no
authority to indicate that any controlled substance being
considered for rescheduling ever has been found to have a
currently accepted medical use merely because it was the source
of an "accepted and useful medication."10 Thus, marihuana
____________________
9 There are some instances in which courts have suggested
that the statutory criteria in 21 U.S.C. 812 are not mandatory,
but are factors to be used in a balancing process. See, e.g.,
Fogarty, 692 F.2d at 548 ("the three statutory criteria for
Schedule I classification set out in S 812(b)(1) - high potential
for abuse, no medically accepted use, and no safe use even under
medical supervision - should not be read as being either
cumulative or exclusive"); National Org. for the Reform of
Mariiuana Laws, 559 F.2d at 748 ("placement in Schedule I does
not appear to flow inevitably from lack of a currently accepted
medical use"); National Org. for the Reform of Mariiuana Laws,
488 F. Supp. at 140 ("statutory criteria of section 812(b)(1) are
guides in determining the schedule to which a drug belongs, but
are not dispositive"). Although the meaning of these dicta is
somewhat unclear, DEA has interpreted the CSA to require that a
controlled substance placed by Congress in Schedule I may not be
rescheduled into Schedule II unless it has a currently accepted
medical use. See 54 Fed. Reg. at 53,773; 57 Fed. Reg. at 10,499.
Nothing in this court's recent marihuana rescheduling cases
suggests that DEA's interpretation is incorrect. See Alliance
for Cannabis Therapeutics, 15 F.3d at 1133; Alliance for Cannabis
Therapeutics, 930 F.2d at 938-940. If there is a tension between
some language in older cases and DEA's interpretation of the CSA,
DEA's reasonable interpretation of the CSA is entitled to
deference under Chevron, 467 U.S. at 843-845.
10 In fact, there is authority to the contrary. In 1993,
the DEA proposed to reschedule the levo isomer of
alphacetylmethadol while leaving all other isomers of
alphacetylmethadol in Schedule I because the levo isomer had been
approved by the FDA for treatment of narcotic addiction. See 58
Fed. Reg. 25,790 (1993). Levo-alphacetylmethadol was
subsequently placed in Schedule II. See 21 C.F.R.
1308.12(c)(11). Despite the petitioner's "rules of statutory
construction," alphacetylmethadol (the source of this accepted
16
plants themselves must have a "currently accepted medical use" in
order to satisfy the rescheduling criterion in 21 U.S.C.
812(b)(2)(B). Because the petitioner's request raised no doubts
about DEA's recent findings that marihuana plants have no
currently accepted medical use, DEA acted properly when it
declined to initiate proceedings to reschedule marihuana
plants.11
The petitioner's novel theory that a source of an accepted
and useful medication must be moved out of Schedule I is rooted
in a misinterpretation of the then-Administrator's letter.
Although the letter attempted to explain why Congress may have
chosen to place coca leaves and opium plants in Schedule II,
nothing in the letter states or even suggests that Congress, the
Attorney General, DEA or the courts have adopted a general rule
of statutory construction that whenever a plant is the source of
an accepted and useful medication, it must be rescheduled.
Further, nothing in the letter suggests that its text was
intended to serve as some type of binding administrative
interpretation of the CSA. The letter was simply an informal
response to a citizen's question about DEA's recent refusal to
____________________
and useful medication) remains in Schedule I. See 21 C.F.R.
1308.11(b)(4).
11 Even if the statutory language were not clear, DEA's
interpretation of the CSA certainly would be permissible. The
petitioner can point to nothing in the statute, the legislative
history or elsewhere that would suggest that the interpretation
is not reasonable. Accordingly, even if the CSA is ambiguous,
this court should affirm DEA's interpretation. See Chevron, 467
U.S. at 843-844.
17
reschedule marihuana. Such an informal unpublished letter that
does not even purport to be a final agency action cannot have a
binding effect on DEA. See Independent Ins, Agents of Am., Inc.
v. Ludwig, 997 F.2d 958, 962 (D.C. Cir. 1993) (finding that six
unpublished letters of Comptroller of the Currency provided no
reliable evidence of Comptroller policy); USAA Fed. Sav. Bank v.
McLaughlin, 849 F.2d 1505, 1508-1509 (D.C. Cir. 1988) (finding
that informal unpublished letter in response to individuals
specific inquiry did not constitute definitive statement of
Department of Labor policy).
Although there may be some arguable inconsistency between
the scheduling of marihuana plants and the scheduling of coca
leaves and opium plant material, such would not be irrational or
contrary to the CSA. Congress placed all of these substances in
their CSA schedules. These scheduling decisions have been upheld
as rational and constitutional. See, e.g., United States v.
Whitley, 734 F.2d 1129, 1141 (6th Cir. 1984) (not irrational or
unreasonable for Congress to classify cocaine as narcotic
substance under Schedule II of CSA even though cocaine is non-
narcotic central nervous system stimulant); National Org. for the
Reform of Mariluana Laws, 488 F. Supp. at 140 (even if marihuana
does not fall within literal reading of Schedule I,
classification in Schedule I is rational and furthers regulatory
purposes of Congress). DEA and the courts have conducted reviews
of the scheduling decision and have determined that marihuana
should remain in Schedule I. See Alliance for Cannabis
18
Therapeutics, 15 F.3d at 1137. Since the petitioner presented no
new medical, scientific or other information to suggest that
circumstances have changed since DEA's last review, DEA acted
properly when it refused to conduct additional hearings in
response to the petitioner's request to move marihuana from
Schedule I to Schedule II.
IV. THE ADMINISTRATOR PROPERLY DENIED THE PETITION BECAUSE
IT RELIED ON THE INCORRECT ASSUMPTION THAT DRONABINOL
HAS BEEN MOVED TO SCHEDULE II WHEN IN FACT ONLY A
SINGLE PHARMACEUTICAL PRODUCT HAS BEEN MOVED TO
SCHEDULE II.
In addition to relying on a mistaken interpretation of the
CSA, the petitioner also appeared to rely incorrectly upon the
premise that all forms of dronabinol have been rescheduled from
Schedule I to Schedule II. DEA did not promulgate such a
sweeping rule. Rather, DEA has merely rescheduled one particular
pharmaceutical product that has been approved by the FDA.
In May of 1985, the FDA approved a new drug application for
Marinol Capsules, which was submitted by Unimed Incorporated.
Marinol Capsules contain specified quantities of synthetic
dronabinol in sesame oil and encapsulated in round soft gelatin
capsules. See 50 Fed. Reg. 42,186 (1985). DEA then issued a
notice of proposed rulemaking seeking to move this pharmaceutical
product (and no other Schedule I substance) to Schedule II. Id.
After following appropriate rulemaking procedures, on May 13,
1986, the Administrator issued a rule:
to transfer U.S. Food and Drug Administration (FDA)
approved drug products that consist of synthetic
dronabinol in sesame oil encapsulated in soft gelatin
capsules from Schedule I into Schedule II of the
19
Controlled Substances Act (CSA). Dronabinol is the
synthetic equivalent of the isomer of delta-9-
tetrahydrocannabinol (THC) which is the principal
psychoactive substance in Cannabis sativa L.,
marijuana. This action is based on a finding that U.S.
Food and Drug Administration approved drug products
which contain dronabinol fit the statutory criteria for
inclusion in Schedule II of the CSA. . . . This rule
does not affect the Schedule I status of any other
substance, mixture or preparation which is currently
included in 21-CFR 1308-11(d)(21),
Tetrahydrocannabinols.
51 Fed. Reg. 17,476 (1986) (emphasis added).
This rule clearly indicates that only a very specific
substance ("Marinol") was moved from Schedule I to Schedule II.
See 21 C.F.R. 1308.12(f)(1). DEA did not transfer any other
dronabinol products to Schedule II nor did it transfer all
tetrahydrocannabinols or all cannabis products to Schedule II.
See 51 Fed. Reg. at 17,476 ("Dronabinol and all mixtures,
compounds and preparations thereof, except dronabinol in sesame
oil and encapsulated in soft gelatin capsules in a FDA approved
product, remain in Schedule I"). Thus, marihuana plants and
tetrahydrocannabinols remain listed in Schedule I. See 21 C.F.R.
1308.11(d)(18) and 1308.11(d)(26).12
In rejecting the petitioner's request in this case, DEA's
final order correctly explained that dronabinol remains in
Schedule I of the CSA and that only Marinol was placed in
Schedule II in 1986. A. 23. Faced with this explanation and the
____________________
12 Unlike Marinol, marijuana plants contain varying
quantities of over 400 chemicals, including THC, that cannot be
reproduced in standardized dosages. 57 Fed. Reg. at 10,507.
Additionally, no currently approved medicine is administered by
smoking. Id. at 10,499.
20
clear language of DEA's final rule of 1986, the petitioner has
changed his argument. He now claims that dronabinol should have
been placed in Schedule II when the pharmaceutical product
Marinol was rescheduled in 1986. Thus, for the first time on
appeal, the petitioner appears to be challenging the propriety of
the DEA rule that rescheduled Marinol from Schedule I to Schedule
II.13 See 51 Fed. Reg. at 17,476.
The petitioner did not seek this relief below. Nothing in
his petition to DEA suggested that he was challenging the
validity of the rescheduling of Marinol. Similarly, nothing in
the petition suggested that he was petitioning DEA to reschedule
dronabinol or some other substance to Schedule II. The petition
only asked DEA to reschedule marihuana. See A. 2-4. To the
extent that petitioner seeks relief that he did not request in
the proceedings before DEA or challenges the validity of a rule
he did not previously challenge, he should be precluded from
raising these issues for the first time on appeal because he has
failed to exhaust his administrative remedies. See Cutler v.
Hayes, 818 F.2d 879, 890-891 (D.C. Cir. 1987); Randolph-Sheppard
____________________
13 Contrary to the petitioner's assertions, DEA's actions
in rescheduling Marinol were not in conflict with the holding of
Grinspoon v. Drug Enforcement Admin., 828 F.2d 881, 891-892 (lst
Cir. 1987). In Grinspoon, the court specifically found that FDA
approval was sufficient to establish an accepted medical use for
rescheduling determinations under the CSA. Id. at 890. Thus,
DEA properly initiated rescheduling proceedings for Marinol after
it received FDA approval. See 50 Fed. Reg. at 42,186. Although
the Grinspoon court found that the lack of FDA approval did not
preclude a finding of accepted medical use, DEA was not faced
with such a case; the 1985 petition only sought to reschedule
Marinol, a substance that had been approved by the FDA.
21
Vendors of America v. Weinberger, 795 F.2d 90, 104-105 (D.C. Cir.
1986). The court should require the petitioner to exhaust his
administrative remedies on these additional issues because (1) it
is necessary to discourage this prolific petitioner from
frequently and deliberately flouting the administrative process
by raising new issues for the first time on appeal; (2) DEA
should have the first opportunity to consider these issues and
apply its technical expertise in order to protect its autonomy
from judicial intrusion; (3) the record before this court on
these issues is incomplete because the issues were not discussed
in the administrative proceeding; and (4) judicial economy will
be enhanced if the administrative proceedings obviate the need
for judicial involvement. See Fertilizer Institute v. United
States Envtl. Protection Agency, 935 F.2d 1303, 1312-1313 (D.C.
Cir. 1991); Cutler, 818 F.2d at 890-891.
The petitioner is free to bring a separate challenge to the
validity of the rulemaking that rescheduled Marinol or to
petition DEA to reschedule dronabinol or some other substance.
However, no purpose would be served by remanding the instant case
to address either challenge. Even assuming arguendo that the
petitioner could prevail on either challenge, he could not
achieve the ultimate relief he sought in this proceeding --
rescheduling of marihuana plants -- because the language of the
CSA clearly indicates that the scheduling of other substances has
no bearing on the proper scheduling of marihuana plants.
22
CONCLUSION
For the foregoing reasons, this court should affirm DEA's
final order denying the petitioner's request.
Respectfully submitted,
JOHN C. KEENEY
Acting Assistant Attorney General
THERESA M.B. VAN VLIET
Chief
LENA WATKINS
JOHN J. FARLEY
Trial Attorneys
Narcotic and Dangerous Drug Section
Criminal Division
U.S. Department of Justice
P.O. Box 27312, Central Station
Washington, D.C. 20038
(202) 514-0917
Of Counsel:
DENNIS F. HOFFMAN
Drug Enforcement Administration
23
CERTIFICATE OF SERVICE
It is hereby certified that service of this BRIEF FOR THE
RESPONDENT was made on the petitioner on this 6th day of
November, 1995, by mailing two copies, postage prepaid, addressed
as follows.
Carl Eric Olsen
Post Office Box 4091
Des Moines, Iowa 50333
Lena Watkins
Trial Attorney
Narcotic and Dangerous
Drug Section
CERTIFICATION PURSUANT TO D.C. CIRCUIT RULE 28(d)(1)
It is hereby certified that this brief contains no more than
12,500 words in accordance with D.C. Circuit Rule 28(d)(1).
Lena Watkins
Trial Attorney
Narcotic and Dangerous
Drug Section
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