the CSA.  It is dronabinol 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, dronabinol, 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 Schedule II medications cocaine and morphine.  It would be 

illogical for the DEA to place a plant in a higher schedule than 

the drug which caused it to be scheduled in the first place, 

especially when there is no difference between Schedule I and 

Schedule II with regard to enforcement of the drug laws (the 

DEA's only valid concern).



     The Administrator's decision that synthetic dronabinol in 

sesame oil and encapsulated in soft gelatin capsules, but not 

dronabinol itself, has been rescheduled, and that dronabinol is 

not obtained from marijuana, is beyond the scope of the DEA's 

authority.  This distinction is strictly a function of the Food 

and Drug Administration, and only with regard to the marketing of 

a drug, not its scheduling.

     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 

                             - 11 -

schedule a substance under the CSA without first obtaining the 

recommendation of the FDA, through its parent agency, HHS, 21 

U.S.C. § 811(b), and providing an 'opportunity for a hearing 

pursuant to rulemaking procedures prescribed by [the 

Administrative Procedures Act].' 21 U.S.C. § 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 dronabinol in sesame oil and 

encapsulated in soft gelatin capsules), this does not qualify as 

a recommendation, pursuant to 21 U.S.C. § 811(b), to keep the 

                             - 12 -

dronabinol found in the marijuana plant in Schedule I.  FDA did 

not recommended that the dronabinol found in marijuana remain in 

Schedule I when Marinol® was placed in Schedule II, nor did it 

say that synthetic dronabinol was superior to the dronabinol 

found in marijuana.  [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 is 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 

                             - 13 -

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.

     By definition, a synthetic drug is the same as its naturally 

occurring twin.  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]

     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 

                             - 14 -

synthetic dronabinol are the same as those of the dronabinol 

found in marijuana.

     In his final order of March 26, 1992, 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.  The 

Physician's Desk Reference makes no distinction between synthetic 

dronabinol and the dronabinol found in marijuana.

     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, the dronabinol found in marijuana 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).

                             - 15 -

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 found in marijuana.

     In 1986, then Administrator John C. Lawn improperly took 

upon himself the authority to define synthetic dronabinol and 

dronabinol found in marijuana as two separate and distinct 

substances under the CSA.  51 Fed Reg. 17476 (1986).

     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 first be the same 

as its naturally occurring twin before it can receive FDA 

marketing approval for distribution in interstate commerce.  As a 

matter of law, the dronabinol found in marijuana was rescheduled 

                             - 16 -

to Schedule II of the CSA at the same time as synthetic 



     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.  It is important to note 

that medical use is not the only salient concept.  As this Court 

noted in 1977, "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.  


     This Court must review the DEA's final order not to transfer 

marijuana to Schedule II 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 

                             - 17 -

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 


     In this matter, the agency has interpreted the construction 

of the statute at issue.  The explanation given by the 

Administrator for the placement of coca and opium poppy plants in 

Schedule II is that Congress recognized coca and opium poppy 

plants "as the source for a variety of accepted and useful 

medications."  [App., p. 5].  According to this explanation, 

marijuana should have been transferred to Schedule II when it 

became the source of an accepted and useful medication.  The U.S. 

Congress provided a mechanism for transferring marijuana to 

Schedule II (or lower), after its initial placement of marijuana 

in Schedule I of the CSA in 1970, and the DEA's interpretation of 

the statute is reasonable.

                             - 18 -

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."  [App., p. 5].

     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 are placed in the same 

schedule as the drugs themselves.  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.

     Since control for enforcement 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).

                             - 19 -

In his final ruling of May 16, 1994, 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, p. 4 [App., p. 20].  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 

of May 16, 1994, p. 8; App., p. 24], this Court has already ruled 



       Based on the foregoing, I respectfully request this Court to 

rule that: (1) as a matter of law, the dronabinol found in 

marijuana 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.

                              - 20 -

Respectfully submitted,


                              Carl Eric Olsen, pro se
                              Post Office Box 4091
                              Des Moines, Iowa 50333
                              (515) 262-6957

                     CERTIFICATE OF SERVICE

     I hereby certify that two copies of the foregoing 
Petitioner's Brief were mailed to Harry J. Matz, Narcotic and 
Dangerous Drug Section, Criminal Division, P.O. Box 27312, 
Central Station, Washington, D.C. 20530, on this 18th day of 
September, 1995.

                             - 21 -