From: carlolsen@dsm1.dsmnet.com Newsgroups: talk.politics.drugs Subject: DEA MARIJUANA RULING Date: 20 May 1994 21:06:26 GMT Message-ID: <2rj8oi$f4i@dsm6.dsmnet.com> UNITED STATES DEPARTMENT OF JUSTICE Drug Enforcement Administration In the Matter of PETITION OF CARL ERIC OLSEN On Remand From the United States Court of Appeals for the District of Columbia Circuit, No. 93-1109 FINAL ORDER This order is issued pursuant to an Order dated December 9, 1993, from the United States Court of Appeals for the District of Columbia Circuit which remanded the matter of a petition from Carl Eric Olsen to the Drug Enforcement Administration (DEA) for a ruling by the agency. On September 6, 1992, Carl Eric Olsen (Petitioner) of Des Moines, Iowa, submitted a petition requesting that the controlled substance marijuana, be rescheduled from Schedule I to Schedule II of the Controlled Substances Act of 1970 (CSA). The Petitioner's grounds were based on his evaluation of two prior rescheduling actions by the Administrator. See Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules, 51 Fed. Reg. 17476 (1986) and Marijuana Rescheduling Petition, 57 Fed. Reg. 10499 (1992). On October 23, 1992, the-Administrator of Drug Enforcement, Robert C. Bonner, declined to accept his petition. The Petitioner subsequently filed for review of then-Administrator Bonner's decision with the United States Court of Appeals for the District of Columbia Circuit. The matter was remanded by Order of that Court to the DEA for a ruling. Pursuant to that Court's Order, and 21 C.F.R. ' 1308.44(c), the Deputy Administrator of the Drug Enforcement Administration has considered the matters before him and thereby renders his final decision. In his Petition for rescheduling, the Petitioner alleged that marijuana need not have an accepted medical use in treatment in the United States in order to be rescheduled from Schedule I, but "it only needs to be shown that marijuana is a source for an accepted and useful medication". This contention was based on Petitioner's own analogies drawn from an earlier DEA marijuana rescheduling case, 57 Fed. Reg. 10499 (1992), and subsequent written statements made to the Petitioner by then-Administrator Bonner regarding coca leaves and opium plant material; and the Petitioner's incorrect contention that the DEA proposed to reschedule dronabinol in a proposed rulemaking. See Rescheduling of Synthetic Dronabinol in Sesame Oil and Encapsulated in Soft Gelatin Capsules, 50 Fed. Reg. 42186 (1985). It appears that Petitioner contends that this rescheduling action included delta-9-tetrahydrocannabinol (delta-9-THC), an ingredient in marijuana, and concluded that "since marijuana is now a source for an accepted and useful medication, it must now be rescheduled from Schedule I to Schedule II of the CSA". The Deputy Administrator finds, for the reasons stated herein, that the grounds upon which the Petitioner relies are not sufficient to justify the initiation of proceedings for the transfer of marijuana from Schedule I to Schedule II of the CSA. In July 1992, the Petitioner wrote then-Administrator Bonner regarding his final order of March 26, 1992, (57 Fed. Reg. 10499), in which the Administrator declined to reschedule marijuana to Schedule II, and the apparent "unfair" classification of the marijuana plant as a Schedule I substance, while coca and opium plants remained in Schedule II. Then-Administrator Bonner replied by letter on August 17, 1992, and distinguished the pharmaceuticals or derivative compounds from each plant. Apparently, the Petitioner then created a theory, that given that the Schedule II opium and coca plants were a source for accepted medication, then if marijuana plants were a source for accepted medications it should also be a Schedule II substance. To further his argument, the Petitioner pointed to the rescheduled drug, which he called dronabinol, as having its source in marijuana. The Petitioner also alluded to inconsistencies of scheduling of delta-9-THC, a component of marijuana, between the CSA and certain multilateral international agreements. When the CSA was created, Congress specified the initial scheduling of controlled substances and the criteria by which controlled substances could be rescheduled. 21 U.S.C. '' 811-812. The DEA is bound, by law, to follow this mandate. Congress placed both the tetrahydrocannabinols, which includes delta-9-THC, and the plant marijuana into Schedule I when it enacted the CSA. See Pub. L. 91-513, ' 202(c), Schedule I (c)(17) and (c)(10). Similarly, Congress placed opium poppy and straw and coca leaves into Schedule II. See Pub. L. 91-513, ' 202(c), Schedule II (a)(3) and (a)(4). The legislative history indicates that marijuana was placed into Schedule I on its own merits and not because delta-9-THC could be extracted from it. H.R. Rep. No. 1444, 91st Cong., 2d Sess., pt. 1, at 12 (1970). Whether or not marijuana is a source of delta-9-THC is irrelevant to the status of marijuana under the CSA. With regard to the classification of controlled substances, the Attorney General may, by rule, add to the established schedules or transfer between such schedules and drug or other substance if [s]he finds that such drug or other substance has a potential for abuse, and makes with respect to such drug or other substance the findings prescribed by subsection (b) of Section 812 for the schedule in which such drug is to be placed. 21 U.S.C. ' 811(a)(1). The Attorney General has delegated this authority to the Administrator, who has redelegated it to the Deputy Administrator. See 28 C.F.R. '' 0.100(b) and 0.104. (59 Fed. Reg. 23637 (May 6, 1994)). In order for a substance to be placed into Schedule II, the Attorney General must find that: "(A) The drug or other substance has a high potential for abuse. (B) The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. (C) Abuse of the drug or other substance may lead to severe psychological or physical dependence." 21 U.S.C. ' 812(b)(2). Then-Administrator John C. Lawn previously determined that marijuana does not have a currently accepted medical use in treatment in the United States and as a result must remain in Schedule I. See Marijuana Rescheduling Petition, 54 Fed. Reg. 53767 (1989). Then-Administrator Lawn's final order was appealed to the United States Circuit Court of Appeals for the D.C. Circuit which returned the matter to the DEA for an explanation of the factors relied upon in determining "currently accepted medical use". See Alliance for Cannabis Therapeutics v. DEA, 930 F.2d 936 (D.C. Cir. 1991). In response to the remand, then-Administrator Bonner issued a final order in which he determined that for a substance to have a "currently accepted medical use" the following must exist: a. the drug's chemistry must be known and reproducible; b. there must be adequate safety studies; c. there must be adequate and well-controlled studies proving efficacy; d. the drug must be accepted by qualified experts; and e. the scientific evidence must be widely available. Then-Administrator Bonner concluded that marijuana failed to meet all elements of the five-part test and, therefore, did not meet the statutorily prescribed criteria for a Schedule II substance. Marijuana Rescheduling Petition, 57 Fed. Reg. 10499 (1992); See Alliance for Cannabis Therapeutics v. DEA, et al., 15 F.3d 1131 (D.C. Cir. 1994) upholding the Administrator's decision. Accordingly, the Deputy Administrator concludes that the Petitioner's contention that marijuana need not have an accepted medical use in treatment in the United States in order to be rescheduled from Schedule I to Schedule II of the CSA is not in accordance with law. DEA may only move a drug from Schedule I if there is a finding of "currently accepted medical use in treatment in the United states". Although delta-9-THC is the principle psychoactive ingredient in marijuana, it can be synthesized and exist as a chemical. Delta-9-THC is a generic term which refers to four separate chemicals and two mixtures of chemicals, i.e., four stereochemical variants of the parent substance and two racemates. One of the stereochemical variants, the (-) delta-9-trans-THC isomer, is the principle psychoactive ingredient in Cannabis sativa, L., or marijuana. That isomer is also the ingredient in a pharmaceutical product which has been shown to be safe and effective as an anti-emetic for certain patients receiving cancer chemotherapy, and is identified chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-p yran-1-ol. The International Nonproprietary name (INN) and the U.S. Adopted Name (USAN) for that isomer of delta-9-THC is dronabinol. With the development of scientific and medical evidence that demonstrated that a pharmaceutical product which contained dronabinol was safe and effective for the treatment of nausea and vomiting associated with cancer chemotherapy in certain patients, then-Administrator John C. Lawn rescheduled this pharmaceutical product from Schedule I to Schedule II. See 51 Fed. Reg. 17476 (1986). Only the pharmaceutical product was transferred from Schedule I to Schedule II, i.e., "dronabinol (synthetic) in sesame oil and encapsulated in soft gelatin capsules in a U.S. Food and Drug Administration approved drug product". No rescheduling action was taken with regard to (-) delta-9-trans-THC, i.e., dronabinol, which remains in Schedule I of the CSA. Tetrahydrocannabinols, including delta-9-THC, one of the synthetic equivalents of the substances contained in the plant or resinous extractives of Cannabis (marijuana) are listed at 21 C.F.R. ' 1308.11(d)(25). Tetrahydrocannabinols and all their isomers, including delta-9-THC, are also the subject of control by international agreement under the United Nations Convention on Psychotropic Substances, 1971, February 21, 1971, 32 U.S.T. 543, T.I.A.S. 9725, 1019 U.N.T.S. 175. Cannabis, cannabis resin and extracts and tinctures of cannabis are regulated as Schedule I substances under the United Nations Single Convention on Narcotic Drugs, 1961, March 30, 1961, 18 U.S.T. 1407, T.I.A.S. 6298, 520 U.N.T.S. 204. The United States is a party to both conventions. Then-Administrator Lawn also discussed the United States international obligations in his Dronabinol in Sesame Oil and Encapsulated in a Soft Gelatin Capsule, rescheduling action. See 51 Fed. Reg. 17476 (1986). Since Article 7 of the Convention on Psychotropic Substances, 1971 has strict prohibitions on activities involving Schedule I drugs, in 1987, the United States Government initiated an action to have delta-9-THC transferred to Schedule II to allow the pharmaceutical product to be marketed. See U.N. Doc. E/CN.7/1990/4. Such a transfer was not inconsistent with the substance delta-9-THC remaining in the CSA Schedule I. Under Article 23 of the Convention on Psychotropic Substances, 1971, a party may adopt more strict or severe measures of control if desirable or necessary for the protection of the public health and welfare. Under the CSA, the regulation of chemicals and the plant material are distinct from each other. The classification of delta-9-THC has no bearing on the classification of marijuana. Under the CSA, a proposed change in the schedule of either a tetrahydrocannabinol or the plant marijuana requires the Attorney General to proceed independently. Petitioner apparently does not wish to look to the clear construct of the Controlled Substances Act, but to pose alternative theories of the Act. Under the CSA, drugs or other substances may be treated and classified differently, according to the enumerated statutory criteria. 21 U.S.C. ' 812(b). The Deputy Administrator reaffirms that marijuana does not have a currently accepted medical use in treatment in the United States and is thus appropriately listed as a Schedule I controlled substance. The Deputy Administrator finds nothing to support the petitioner's contention that since marijuana, coca, and opium are all plant materials they must be treated alike in the CSA. The Deputy Administrator further finds that the rescheduling of the pharmaceutical product "dronabinol (synthetic) in sesame oil and encapsulated in a soft gelatin capsule in a U.S. Food and Drug Administration approved drug product", which contains the synthetic chemical ingredient (-) delta-9-trans-THC, did not require that either the plant marijuana or substance delta-9-THC be similarly rescheduled. The Petitioner's request is denied. Stephen H. Greene Deputy Administrator Dated: May 16, 1994 ============================================================================= From: carlolsen@dsm1.dsmnet.com Newsgroups: talk.politics.drugs Subject: REPLY TO DEA RULING Date: 24 May 1994 16:23:11 GMT Message-ID: <2rt9lf$o9p@dsm6.dsmnet.com> 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 "carlolsen@dsm1.dsmnet.com" or "iowanorml@commonlink.com" Thanks. -- Carl