From: [c--o--n] at [dsm1.dsmnet.com]
Newsgroups: talk.politics.drugs
Subject: REPLY TO DEA RULING
Date: 24 May 1994 16:23:11 GMT

UNITED STATES DEPARTMENT OF JUSTICE
Drug Enforcement Administration
 
In the Matter of
PETITION OF CARL ERIC OLSEN
On Remand From the
United States Court
of Appeals for the
District of Columbia
Circuit, No. 93-1109
 
PRELIMINARY DRAFT OF APPEAL FROM FINAL ORDER
        On May 16, 1994, the Deputy Administrator of the Drug Enforcement 
Administration (DEA) erroneously denied my petition to have marijuana 
transferred from Schedule I to Schedule II of the Controlled Substances Act 
(CSA), 21 U.S.C. '' 801 et seq.  The DEA Deputy Administrator erred by 
erroneously ruling that: (1) marijuana must have a medical use in treatment 
in the United States before it can be transferred to Schedule II of the CSA; 
(2) only synthetic dronabinol in sesame oil and encapsulated in soft gelatin 
capsules, not dronabinol itself, was transferred to Schedule II of the CSA; 
and (3) whether or not marijuana is a source of delta-9-tetrahydrocannabinol 
(THC) is irrelevant to the status of marijuana under the CSA.
        In my petition for rescheduling, I alleged that marijuana need not 
have an accepted medical use in treatment in the United States in order to 
be rescheduled from Schedule I, but "it only needs to be shown that 
marijuana is a source for an accepted and useful medication".  In his final 
ruling, the DEA Deputy Administrator said, "This contention was based on 
Petitioners own analogies drawn from an earlier DEA marijuana rescheduling 
case, 57 Fed. Reg. 10499 (1992), and subsequent written statements made to 
the Petitioner by then-Administrator Bonner regarding coca leaves and opium 
plant material;..."  FINAL ORDER, at page 2 (May 16, 1994).
        The DEA Deputy Administrator cites the case of Alliance for Cannabis 
Therapeutics v. DEA, 15 F.3d 1131 (D.C. Cir. 1994) to support his theory 
that marijuana may only be moved from Schedule I if there is a finding of 
"currently accepted medical use in treatment in the United States."  The 
parties agreed that nothing which has a currently accepted medical use in 
treatment can be included in Schedule I, and the question of whether 
marijuana has a currently accepted medical use in treatment was the sole 
issue in that case.  The question of whether marijuana could be moved from 
Schedule I without a currently accepted medical use in treatment was not an 
issue in that case.  In 1977, the United States Court of Appeals for the 
District of Columbia Circuit considered this exact question when it ruled, 
"[P]lacement in Schedule I does not appear to flow inevitably from lack of 
currently accepted medical use.  ...The legislative history of the CSA 
indicates that medical use is but one factor to be considered, and by no 
means the most important one."  National Organization for the Reform of 
Marijuana Laws v. DEA, 559 F.2d 735, 748 (D.C. Cir. 1977).
        In my petition for rescheduling, I also allege that the DEA proposed 
to reschedule dronabinol in a proposed rulemaking.  See Rescheduling of 
Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin 
Capsules, 50 Fed. Reg. 42186 (1985).  In his final ruling the DEA Deputy 
Administrator said, "It appears that Petitioner contends that this 
rescheduling action included delta-9-tetrahydrocannabinol (delta-9-THC), an 
ingredient in marijuana, and concluded that since marijuana is now a source 
for an accepted and useful medication, it must now be rescheduled from 
Schedule I to Schedule II of the CSA".  FINAL ORDER, at page 2.
        Although the DEA Deputy Administrator points out that I have 
incorrectly identified dronabinol as delta-9-THC, the Deputy Administrator 
admits that the correct ingredient, the (-) delta-9-trans-THC isomer of 
delta-9-THC, is the principle psychoactive ingredient in Cannabis sativa, 
L., or marijuana.  The Deputy Administrator argues that dronabinol was not 
transferred to Schedule II of the CSA, and that only "dronabinol (synthetic) 
in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and 
Drug Administration approved drug product" has been transferred to Schedule 
II of the CSA.  This is a distinction that the Deputy Administrator does not 
have the authority to make.  FDA marketing approval is not a prerequisite 
for the rescheduling of a drug.  Alliance for Cannabis Therapeutics v. DEA, 
930 F.2d 936, 939-40 (D.C. Cir. 1991); Grinspoon v. DEA, 828 F.2d 881, 887 
(1st Cir. 1987).  Certainly, the Deputy Administrator would not make the 
claim that sesame oil and soft gelatin capsules, by themselves, belong in 
any schedule of the CSA.  Is the Deputy Administrator saying that the 
addition of sesame oil and soft gelatin capsules to dronabinol create 
therapeutic value in dronabinol where none existed before, or that synthetic 
dronabinol has therapeutic value while its twin obtained from the plant 
material has none?
        The DEA Deputy Administrator points out that both delta-9-THC and 
marijuana are subject to international control, delta-9-THC under the United 
Nations Convention on Psychotropic Substances, 1971, February 21, 1971, 32 
U.S.T. 543, T.I.A.S. 9725, 1019 U.N.T.S. 175, and marijuana under the United 
Nations Single Convention on Narcotic Drugs, 1961, March 30, 1961, 18 U.S.T. 
543, T.I.A.S. 6298, 520 U.N.T.S. 204, and that the United States is a party 
to both conventions.  In 1977, The United States Court of Appeals for the 
District of Columbia Circuit ruled that the United States may place 
marijuana in either Schedule I or Schedule II of the CSA without violating 
its international obligations.  National Organization for the Reform of 
Marijuana Laws v. DEA, 559 F.2d 735, 757 (D.C. Cir. 1977).
        The DEA Deputy Administrator admits, "Since Article 7 of the 
Convention on Psychotropic Substances, 1971 has strict prohibitions on 
activities involving Schedule I drugs, in 1987, the United States Government 
initiated an action to have delta-9-THC transferred to Schedule II to allow 
the pharmaceutical product to be marketed.  See U.N. Doc. E/CN.7/1990/4."  
FINAL ORDER, at page 8.  The United States could have sought only the 
transfer of "dronabinol (synthetic) in sesame oil and encapsulated in a soft 
gelatin capsule in a U.S. Food and Drug Administration approved drug 
product," but instead chose to seek the transfer of all delta-9-THC isomers 
and racemates, whether obtained synthetically or from the plant material 
itself.
        In his final ruling, the DEA Deputy Administrator said, "the 
regulation of chemicals and the plant material are distinct from each 
other."  FINAL ORDER, at page 8.  However, in a letter dated August 17, 
1992, then DEA Administrator Robert C. Bonner said, "In placing coca leaves 
and opium plant material in Schedule II, Congress was very much aware that 
these plant materials have historically been recognized as the source for a 
variety of accepted and useful medications."  Then Administrator Bonner 
recognized, as the U.S. Supreme Court did in 1984, "If the intent of 
Congress is clear, that is the end of the matter; for the court, as well as 
the agency, must give effect to the unambiguously expressed intent of 
Congress.  ...[I]f the statute is silent or ambiguous with respect to the 
specific issue, the question for the court is whether the agencys answer is 
based on a permissible construction of the statute."  Chevron U.S.A., Inc. 
v. Natural Resources Defense Council, Inc., 467 U.S. 837, 842-843, 104 S.Ct. 
2778, 2781-2782, 81 L.Ed.2d 694 (1984).  It is clear that Congress placed 
coca and opium into Schedule II because they were sources for accepted and 
useful medications, and it is equally clear that, "Neither of these plants 
are used medicinally as plant material."  See DEA Administrator Bonners 
letter of August 17, 1992.  Clearly, marijuana, like coca and opium, could 
be placed in Schedule II without having a currently accepted medical use in 
treatment in the United States and without violating international treaty 
obligations.  It only needs to be shown that marijuana is the source of 
accepted and useful medicines.  Investigations have also shown that other 
drugs, other than (-) delta-9-trans-THC, in the marijuana plant may have 
therapeutic value, but the placement of marijuana in Schedule I makes such 
investigations difficult, if not impossible, which is why Congress chose to 
place coca and opium in Schedule II rather than Schedule I.
        In his final ruling, the DEA Deputy Administrator said, "Whether or 
not marijuana is a source of delta-9-THC is irrelevant to the status of 
marijuana under the CSA."  FINAL ORDER, at page 4.  In 1975, the United 
States Court of Appeals for the District of Columbia Circuit gave detailed 
consideration to this question in the case of United States v. Walton, 514 
F.2d 201 (D.C. Cir. 1975). The court said, "Looking at the history of this 
latter law [the Marijuana Tax Act of 1937], we find that the definition of 
marijuana was intended to include those parts of marijuana which contain THC 
and to exclude those parts which do not."  Id. 514 F.2d at 203.  "The 
legislative history is absolutely clear that Congress meant to outlaw all 
plants popularly known as marijuana to the extent those plants possessed 
THC."  Id. 514 F.2d at 203-204.  Although the Deputy Administrator said, 
"The classification of delta-9-THC has no bearing on the classification of 
marijuana." [FINAL ORDER, at page 8], the court has already ruled otherwise.
        Carl E. Olsen
May 24, 1994

Please send any comments or suggestions by email to Carl E. Olsen
"[c--o--n] at [dsm1.dsmnet.com]" or "[iowanor m l] at [commonlink.com]"
Thanks.  -- Carl