# Lyle E. Craker; Denial of Application

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3AE9-521

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** January 14, 2009
- **Citation:** 74 FR 2101

## Text

DEPARMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 05-16]
Lyle E. Craker; Denial of Application
On December 10, 2004, the Deputy Assistant Administrator, Office of Diversion Control, issued an Order to Show Cause to Lyle E. Craker, Ph.D. (Respondent), of Amherst, Massachusetts. The Show Cause Order proposed the denial of Respondent's pending application for a registration as a bulk manufacturer of marijuana on two grounds. Show Cause Order at 1.

First, the Show Cause Order alleged that Respondent's “registration would not be consistent with the public interest as that term is used in 21 U.S.C. 823(a).” Show Cause Order at 1. Second, the Show Cause Order alleged that the Respondent's registration would be inconsistent “with the United States'

obligations under the Single Convention on Narcotic Drugs (Single Convention), March 30, 1961, 18 U.S.T. 1407.”
Id.

With respect to both of these contentions, noting that Respondent sought registration “to supply analytical, pre-clinical and clinical researchers with marijuana,” the Show Cause Order emphasized that the “National Institute on Drug Abuse (NIDA), a component [of] the National Institutes of Health (NIH)” and “the United States Department of Health and Human Services [HHS], oversees the cultivation, production and distribution of research-grade marijuana on behalf of the United States Government.”
Id.
at 2.

With respect to the contention that Respondent's proposed registration is inconsistent with the public interest, the Show Cause Order stated that, under 21 U.S.C. 823(a), “DEA must limit the number of producers of research-grade marijuana to that which can provide an adequate and uninterrupted supply under adequately competitive conditions.”
Id.
at 4. The Show Cause Order then stated: “For the past 36 years, the University of Mississippi has provided such supply under the foregoing criteria, and there is no indication that this registrant will fail to do so throughout the duration of its current registration. While the University of Massachusetts is free to compete with the University of Mississippi to obtain the next NIDA contract to produce research-grade marijuana, there is no basis under Section 823(a) to add an additional producer.”
Id.

With respect to the contention of Respondent's sponsor, the Multidisciplinary Association for Psychedelic Studies (MAPS), that marijuana provided by NIDA to researchers was both qualitatively and quantitatively inadequate, the Show Cause Order alleged that marijuana provided by NIDA was “of sufficient quantity and quality to meet” the needs of “legitimate and authorized research[ers].”
Id.
at 3.

The Show Cause Order also noted MAPS's contentions that “NIDA is limited to supplying marijuana for research purposes and cannot supply marijuana on a prescription basis,” that “this limitation effectively prohibits a sponsor * * * from expending the necessary large amounts of funds to conduct drug development studies resulting in [a] marijuana prescription product,” and that granting Respondent a registration would resolve this problem.
Id.
In response to these contentions, the Show Cause Order alleged that to obtain approval for the marketing of a new drug under the Food, Drug, and Cosmetic Act (FDCA), the safety and effectiveness of the drug must be demonstrated through three phases of clinical trials, and that clinical trials involving marijuana had not progressed beyond the first phase (phase 1).
Id.
at 2-4.

The Show Cause Order further noted that the policy of HHS for approving the distribution of marijuana to researchers “has not unduly limited clinical research with marijuana.”
Id.
at 5. More specifically, the Show Cause Order alleged that “[s]ince the year 2000, there have been or are eleven approved clinical trials utilizing smoked marijuana,” and that approved “marijuana researchers administer marijuana to almost 500 human subjects.”
Id.
The Show Cause Order also alleged that since 2000, there were “four approved pre-clinical trials in laboratory and animal modes.”
Id.
at 5. Relatedly, the Show Cause Order also asserted that “DEA has no statutory authority to overturn HHS' policy.”
Id.

With respect to the contention that Respondent's registration would be inconsistent with the United States' obligations under the Single Convention, the Show Cause Order again referenced that HHS, through NIDA, oversees the cultivation, production and distribution of research-grade marijuana on behalf of the United States Government and alleged that “[i]n accordance with the Single Convention, the Federal Government [is required] to limit marijuana available for clinical research to [this] source.”
Id.
at 4.

Respondent timely requested a hearing. The matter was assigned to Administrative Law Judge (ALJ) Mary Ellen Bittner, who conducted a hearing on August 22-26 and December 12-14 and 16, 2005. At the hearing, the parties put on testimonial evidence and introduced documentary evidence. Following the hearing, the parties submitted briefs containing their proposed findings of fact, conclusions of law, and argument.

On February 12, 2007, the ALJ issued her recommended decision. Therein, the ALJ rejected the Government's contention that the Single Convention precluded Respondent's registration. In so holding, the ALJ acknowledged that the Convention requires that its signatories maintain a “government monopoly on importing, exporting, wholesale trading, and maintaining stocks.” ALJ at 82. The ALJ reasoned, however, that “[i]t also appears, although it is not entirely clear, that the marijuana grown by the National Center
1

or by any other registrant for utilization in research would qualify as either ‘medicinal' * * * or as ‘special stocks' within the meaning of” the Convention.
Id.
at 82 (citing Single Convention, art. 1, para. (1)(o) & (x)).

1
The National Center is an entity of the University of Mississippi which currently holds the contract with NIDA for growing marijuana to supply United States researchers.

The ALJ then turned to whether Respondent had established that his registration would be consistent with the public interest when considering the six enumerated factors of 21 U.S.C. 823(a). With respect to the first factor, 21 U.S.C. 823(a)(1), the ALJ first recited the relevant text of this provision, which requires DEA to consider maintenance of effective controls against diversion by limiting the manufacturing of schedule I or II controlled substances “to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes.” ALJ at 82 (quoting § 823(a)(1)). Noting that there is precedent for the agency to interpret this provision in two distinct ways regarding the issue of adequacy of competition (either by considering or not considering the issue),
2

the ALJ stated that she would evaluate the issue in both ways.
Id.
at 83.

2
The meaning of 21 U.S.C. 823(a)(1) and the competition issue are discussed in detail in part C of the discussion section of this final order.

Under the first approach of interpreting 21 U.S.C. 823(a)(1) to allow DEA to disregard the issue of adequacy of competition as long as the agency finds that the applicant for registration would provide effective controls against diversion, the ALJ concluded that “there is no evidence or contention that either Respondent or anyone working with him would be likely to divert the marijuana from the growing or drying or storage areas.”
Id.

The ALJ next rejected the Government's contention that there was a risk of diversion because Mr. Rick Doblin, the Director of MAPS, would determine who was to receive the marijuana. In so holding, the ALJ reasoned that Mr. Doblin would not have physical possession of the marijuana and that Respondent would only send marijuana to researchers with DEA registrations and the requisite approval of HHS. ALJ at 84. The ALJ thus concluded that “the research project has procedures in place to adequately protect against diversion of the marijuana” and that “there is minimal risk of diversion.”
Id.

Under the second approach of interpreting 21 U.S.C. 823(a)(1) to require DEA to consider whether competition is inadequate, the ALJ first turned to whether the supply of marijuana currently available to researchers through HHS is adequate. In this regard, the ALJ found that while “there have been some problems with the marijuana that the National Center produces, * * * a preponderance of the evidence establishes that the quality is generally adequate.”
Id.
The ALJ further found, however, that “NIDA's system for evaluating requests for marijuana for research has resulted in some researchers who hold DEA registrations and requisite approval from [HHS] being unable to conduct their research because NIDA has refused to provide them with marijuana.”
Id.
The ALJ thus concluded “that the existing supply of marijuana is not adequate.”
Id.
The ALJ also concluded that competition is inadequate within the meaning of 21 U.S.C. 823(a)(1).
Id.

3

The ALJ thus held that the first public interest factor, 21 U.S.C. 823(a)(1), supported granting Respondent's application.

3
In so finding, the ALJ rejected the Government's contention that because the NIDA contract is open to competitive bidding, adequate competition exists. According to the ALJ, ``[t]he question is not * * * whether the NIDA process addresses that agency's needs, but whether marijuana is made available to all researchers who have a legitimate need for it in their research. As discussed above, I answer that question in the negative.''
Id.
at 85.

As further support for her conclusion, the ALJ reasoned that ``the NIDA contract requires the contractor to analyze'' marijuana seized by law enforcement agencies, and that ``a qualified cultivator may not be able to fulfill'' this requirement.''
Id.

Under the second public interest factor, 21 U.S.C. 823(a)(2), the ALJ found that there was “neither evidence nor contention that Respondent has not complied with applicable laws” and thus concluded that this factor supported the granting of Respondent's application.
See id.

Under the third public interest factor, 21 U.S.C. 823(a)(3), as to whether granting Respondent's application would promote technical advances in the art of manufacturing controlled substances, the ALJ found that Respondent has “considerable experience in cultivating medicinal plants, which might promote technical advances in the cultivation of marijuana or developing new medications from it.” ALJ at 85-86. The ALJ nonetheless found that “there is not sufficient evidence in the record on which to base a finding as to whether granting Respondent's registration would promote technical advances.”
Id.
at 86.

Under the fourth public interest factor, 21 U.S.C. 823(a)(4), the ALJ found that it was “undisputed that Respondent has never been convicted of any violation of any law pertaining to controlled substances” and therefore this factor weighed in favor of granting the application.
Id.

Under the fifth public interest factor, 21 U.S.C. 823(a)(5), the ALJ considered Respondent's “past experience in manufacturing controlled substances and the existence of effective controls against diversion.”
Id.
The ALJ acknowledged that “Respondent has no experience in manufacturing controlled substances.”
Id.
Noting that Respondent “does have experience in growing medicinal plants” and that “the risk of diversion is minimal,” the ALJ concluded that this factor supported granted the application.
Id.

Finally, under the sixth public interest factor, 21 U.S.C. 823(a)(6), in analyzing such other factors as are relevant to and consistent with public health and safety, the ALJ rejected the Government's contention that granting the application would “circumvent[]” HHS's policy with respect to the provision of marijuana to researchers.
Id.
Reasoning that “the NIH Guidance by its own terms applies to marijuana that [HHS] makes available, [and] not [to] marijuana that might be available from some other legitimate source[,]” the ALJ concluded that “the NIH Guidance is not a factor in determining whether Respondent's application should be granted.”
Id.
The ALJ thus concluded that granting Respondent's application “would be in the public interest,” and recommended that I grant his application.
Id.
at 87.

The Government excepted to the ALJ's decision on numerous grounds, and Respondent filed a response to the Government's exceptions. Thereafter, the record was forwarded to me for final agency action.

Having considered the record as a whole, I hereby issue this Decision and Final Order. For reasons explained more fully below, I reject the ALJ's legal conclusion “that the Single Convention does not preclude registering Respondent.”
Id.
at 82. Moreover, I reject the ALJ's finding that the proposed registration is consistent with the public interest when considering the six factors enumerated in 21 U.S.C. 823(a).
Id.
at 82-86. I therefore reject the ALJ's recommendation that the application be granted.
See id.
at 87.

Findings

Under Federal Law, marijuana and tetrahydrocannabinols (THC) are schedule I controlled substances. 21 U.S.C. 812(c), Schedule I(c)(10) & (17). Congress placed marijuana and THC in schedule I because the substances have “a high potential for abuse,” “no current accepted medical use in treatment in the United States,” and “a lack of accepted safety for use * * * under medical supervision.” 21 U.S.C. 812(b)(1).
See also
66 FR 20038 (2001) (denying petition to reschedule marijuana from schedule I),
petition for review dismissed
,
Gettman
v.
DEA
, 290 F.3d 430 (D.C. Cir. 2002).
4

4
As related in the Notice, the FDA recommended that marijuana be maintained in schedule I of the CSA. The FDA based its finding on,
inter alia,
the extensive evidence that marijuana has a history and pattern of abuse, that it is ``[t]he most frequently used illicit drug,'' and that it ``has a high potential for abuse.'' 66 FR at 20047 & 20051. The FDA also found that ``[t]here are not FDA-approved medical products,'' ``marijuana does not have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions,'' and ``that, even under medical supervision, marijuana has not been shown to have an acceptable level of safety.'' 66 FR at 20052.

Marijuana is cultivated from the cannabis plant, which is recognized as “a very adaptive plant [whose] characteristics are even more variable than most plants.” GX 25, at 7. Marijuana, which consists primarily of the dried flowering tops and leaves of the cannabis plant,
5

“is a variable and complex mixture of biologically active compounds.”
Id.
As of 2001, 483 different chemical constituents had been identified in marijuana, including approximately 66 cannabinoids.
6

66 FR at 20041; Tr. 1142, 1147. “THC
7

is the main psychoactive cannabinoid in marijuana”; the plant, however, also contains “[v]arying proportions of other cannabinoids, mainly cannabidiol (CBD) and cannabinol (CBN),” which “sometimes [exist] in quantities that might modify the pharmacology of THC or cause effects of their own.”
Id.
at 7-8.

5
The legal definition of marijuana, as set forth in the CSA, 21 U.S.C. 802(16), is as follows: The term ``marihuana'' means all parts of the plant Cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. Such term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

6
Cannabinoids are chemical compounds that are unique to the cannabis plant (not found in any other plant). Tr. 1140-41.

7
While there are numerous isomers of THC (all of which fall within the listing of ``Tetrahydrocannabinols'' in schedule I of the CSA and many of which are found in the cannabis plant), delta-9-THC is the isomer that is recognized as the primary psychoactive component in marijuana and, for this reason the term ``THC'' is often used to refer to delta-9-THC.
See
66 FR at 20045; Tr. 1146-47.

The National Center and NIDA's Drug Supply Program

Since 1968, the National Center for Natural Products Research (National Center), a division of the University of Mississippi, has held a contract with the Federal Government to grow marijuana for research purposes and held the requisite registrations under the Controlled Substances Act (CSA), as well as the federal law that preceded the CSA, authorizing the University to conduct such activity.
8

Tr. 1152-53, 1350-51.
See also
21 CFR 1301.13. The contract, which is open for competitive bidding at periodic intervals,
see
GX 15, is administered by NIDA, a component of NIH (which is part of HHS), pursuant to its Drug Supply Program. RX 1, at 231. Since 1999, the term of the contract has been five years.
See
GXs 13 & 15; Tr. 1156.

8
Initially, the National Center obtained a researcher's registration; it now also holds a manufacturer's registration.

Under the NIDA contract, the National Center “[g]row[s], harvest[s], store[s], ship[s] and analyze[s] cannabis of different varieties, as required.” GX 13, at 6. The contract requires that the National Center “shall serve as NIDA's cannabis drug repository,” as well as “develop and produce standardized marijuana cigarettes within a range of specified THC content, and placebos for use in pre-clinical and clinical research programs,” and maintain minimum stocks of both bulk marijuana and marijuana cigarettes of various THC contents, and store them in a DEA approved facility.
Id.
at 6-7.

Marijuana potency is primarily based on the concentration (percentage by weight) of THC in the plant material. Tr. 1148-49. As of August 25, 2005, the National Center held on behalf of NIDA approximately 1055 kilograms (kg) of marijuana with THC contents ranging up to 12.26 percent.
See
RX 53. This inventory includes six batches of marijuana with THC contents ranging from 9.02 to 9.89 percent,
9

one batch (of nearly 19 kg) with a THC content of 10 percent, nearly 25 kg with a THC content of 11.34 percent, and approximately 27 kg with a THC content of 12.26 percent.
10

See id
. In his testimony, Mahmoud ElSohly, Ph.D., who is the Principal Investigator under the NIDA contract, and who has overseen the National Center's work with marijuana since 1980, stated that the Center is capable of producing marijuana with a THC content of 20 percent or more.
11

Tr. 1130-31, 1152, 1203, 1254-55.

9
These batches range from approximately 12 to 15 kg in size.

10
As of the date of the hearing, more than 920,000 marijuana cigarettes of various THC concentrations including placebo had been manufactured pursuant to the NIDA contracts between 1974 and 2003. GX 27.

11
11 As Dr. ElSohly explained, he has grown numerous strains of marijuana from seeds that have been obtained from a variety of countries and has used them to do “genetic selection to have genetic material of high potency.” Tr. 1255.

The contract also requires the National Center to “ship to research investigators as authorized by the [NIDA] Project Officer upon receipt of a shipment order.” GX 13, at 7. While the NIDA “Project Officer may pre-authorize any normal recurring requests that the contractor will then fill once it has received” various assurances,
12

the contract further states that “[a]ll other requests should be submitted to the NIDA Project Officer for approval.”
Id
. at 8. Moreover, “[i]f there is a reason to question a particular request, the Contractor shall inform the NIDA Project Officer who will make a final decision on providing the material and quantity requested.”
Id
. As these provisions make clear, the National Center has no authority to distribute any of the marijuana it produces pursuant to the NIDA contract without NIDA's approval.
13

12
These include that the researcher have the appropriate DEA registration and FDA/IND approvals, provide assurance that the marijuana “will not be resold” and “will be used only for research or patient purposes,” that the use of the marijuana will adhere to the appropriate Safety Standards for research,” and that the researcher agree “to comply with all Federal, State and Local Safety requirements for use of the materials.”
See
GX 13, at 8.

13
Independent of its contract with NIDA, the National Center holds an additional registration to manufacture marijuana and THC. GXs 75 & 78. The National Center was granted this registration under the terms of a Memorandum of Agreement (MOA) entered into with DEA in 1999. GX 78. As set forth in the MOA, the purpose of the registration was “to allow the Center to develop a new product formulation for effecting delivery of [THC] in a pharmaceutically acceptable dosage form suppository * * * and to provide crude THC extract to a DEA-registered manufacturer of THC for further purification.”
Id
. at 2. The MOA further stated that, under the terms thereof, the Center would “manufacture marijuana for the purpose of extracting THC therefrom.”
Id
. Subsequently, the Center submitted a new application for a registration to bulk manufacture marijuana and THC “to prepare marihuana extract for further purification into bulk active [THC] for use in launching FDA-approved pharmaceutical products.” 70 FR 47232 (2005). DEA has not yet issued a final order as to this application. (DEA publishes in the
Federal Register
all final orders on applications for registration to bulk manufacture schedule I and II controlled substances.)

The MOA further provided that “[i]n accordance with articles 23 and 28 of the Single Convention on Narcotic Drugs * * * private trade in ‘cannabis' is strictly prohibited. Therefore, the Center shall not distribute any quantity of marijuana to any person other than an authorized DEA employee.” GX 78, at 2. Continuing, the MOA explained that “[t]he Single Convention does not prohibit private trade in ‘cannabis preparations,’ ” and noted that this term, “within the meaning of the Single Convention, is a mixture, solid or liquid containing cannabis, cannabis resin, or extracts or tinctures of cannabis.”
Id
. Because “[t]he THC that the Center will extract from marijuana [is] considered such a ‘cannabis preparation[,]' * * * the Center may, in accordance with the Single Convention, distribute the crude THC extract to private entities” provided the Center otherwise complies with the CSA and DEA regulations.
Id
. at 2-3. The MOA also set forth a detailed series of controls to maintain accountability of the marijuana from acquisition of the seeds through the extraction of THC from the harvested material.
Id
. at 3-7.

In 1997, the White House Office of National Drug Control Policy asked the Institute of Medicine (IOM), a component of the National Academy of Sciences, to conduct a review of the scientific evidence regarding the potential health benefits and risks of marijuana and its constituent cannabinoids. RX 1, at 7. In 1999, the IOM published its report. The IOM found, among other things, that “[d]efined substances, such as purified cannabinoid compounds, are preferable to plant products, which are of variable and uncertain composition. Use of defined cannabinoids permits a more precise evaluation of their effects, whether in combination or alone.” RX 1, at 22. With respect to this issue, the IOM reached the following conclusion: “Scientific data indicate the potential therapeutic value of cannabinoid drugs, primarily THC, for pain relief, control of nausea and vomiting, and appetite stimulation; smoked marijuana, however, is a crude THC delivery system that also delivers harmful substances.” Id. The report further stated:

The therapeutic effects of cannabinoids are most well established for THC, which is the primary psychoactive ingredient of marijuana. But it does not follow from this that smoking marijuana is good medicine.

Although marijuana smoke delivers THC and other cannabinoids to the body, it also delivers harmful substances, including most of those found in tobacco smoke. In addition, plants contain a variable mixture of biologically active compounds and cannot be expected to provide a precisely defined drug effect. For those reasons there is little future in smoked marijuana as a medically approved medication. If there is any future in cannabinoid drugs, it lies with agents of more certain, not less certain, composition.”
14

14
To similar effect, an ad hoc group of experts, who were selected by NIH and convened in 1997 as part of a workshop to assess the potential medical uses of marijuana, issued a report to the Director of NIH, which noted:

As with any smoked drug (e.g., nicotine or cocaine), characterizing the pharmacokinetics of THC and other cannabinoids from smoked marijuana is a challenge. A person's smoking behavior during an experiment is difficult for a researcher to control. People differ. Smoking behavior is not easily quantified. An experienced marijuana smoker can titrate and regulate doses to obtain the desired acute psychological effects and

to avoid overdose and/or minimize undesired effects. Each puff delivers a discrete dose of THC to the body. Puff and inhalation volume changes with phase of smoking, tending to be highest at the beginning and lowest at the end of smoking a cigarette. * * * During smoking, as the cigarette length shortens, the concentration of THC in the remaining marijuana increases; thus, each successive puff contains an increasing concentration of THC.

One consequence of this complicated process is that an experienced marijuana smoker can regulate almost on a puff-by-puff basis the dose of THC delivered to lungs and thence to brain. A less experienced smoker is more likely to overdose or underdose. Thus a marijuana researcher attempting to control or specify dose in a pharmacologic experiment with smoked marijuana has only partial control over the drug dose actually delivered.

See
GX 25, at 9-10 (Workshop on the Medical Utility of Marijuana).

Id
. at 195-96.
See also
GX 53 (letter from Alice P. Mead, GW Pharmaceuticals, P.L.C., to Christine V. Beato, Acting Asst. Sec. for Health, HHS (Apr. 12, 2005)) (“[H]erbal cannabis should comprise only the starting material from which a
bona fide
medical product is ultimately derived. * * * [S]tandardizing herbal starting material represents only the first of many steps necessary to create a modern medicine that is safe and effective for use in specific medical conditions. * * * [A] final medical product * * * must also be delivered in a dosage form that is consistent in composition and that allows the patient to obtain an identifiable and reliable amount of medication.”) (emphasis in original).

Accordingly, the IOM recommended that clinical trials using cannabinoid drugs should be conducted with “the goal of developing rapid-onset, reliable, and safe delivery systems.”
Id.
at 197. The IOM also advised that clinical trials involving smoked marijuana “should involve only short-term marijuana use (less than six months), should be conducted in patients with conditions for which there is a reasonable expectation of efficacy, should be approved by institutional review boards, and should collect data about efficacy.”
Id
.

Also in 1999, due in part to an increased interest in marijuana research and taking into account the IOM report, HHS decided to change the procedures by which it would supply marijuana to researchers. Tr. 1632-33; GX 24. The new procedures were announced in a document released by NIH on May 21, 1999. GX 24, at 1. In the announcement, “HHS recognize[d] the need for objective evaluations of the potential merits of cannabinoids for medical uses[,]” and that “[i]f a positive benefit is found, * * * the need to stimulate development of alternative, safer dosage forms.”
Id
. at 2. Toward this end, NIH explained that the new procedures were designed to increase the availability of marijuana for research purposes by, among other things, making such marijuana “available on a cost-reimbursable basis.”
Id
. This new procedure allowed researchers who were privately funded to obtain marijuana from HHS by reimbursing the NIDA contractor for the cost of the marijuana. Tr. 1633;
see also
GX 31, at 3. This was a departure from the prior practice (pre-1999), whereby HHS only made marijuana available to persons who received NIH funding.
Id
. The new procedures implemented by HHS in 1999 remain in effect today. Tr. 1629.

HHS further stated in 1999 that it intended through the new procedures “to make available a sufficient amount of research-grade marijuana to support those studies that are the most likely to yield usable, essential data.” GX 24, at 2. With respect to those researchers who do not have NIH funding, HHS explained that “the scientific merits of each protocol will be evaluated through a Public Health Service interdisciplinary review process [which] will take into consideration a number of factors, including the scientific quality of the proposed study, the quality of the organization's peer-review process, and the objective of the proposed research.”
Id
.

HHS then identified the criteria it would apply in evaluating requests for marijuana:

The extent to which the protocol incorporates the elements of good clinical and laboratory research;

The extent to which the protocol describes an adequate and well-controlled clinical study to evaluate the safety and effectiveness of marijuana and its constituent cannabinoids in the treatment of a serious or life threatening condition;

The extent to which the protocol describes an adequate and well-controlled clinical study to evaluate the safety and effectiveness of marijuana and its constituent cannabinoids for a use for which there are no alternative therapies;

The extent to which the protocol describes a biopharmaceutical study designed to support the development of a dosage form alternative to smoking; [and]

The extent to which the protocol describes high-quality research designed to address basic, unanswered scientific questions about the effects of marijuana and its constituent cannabinoids or about the safety or toxicity of smoked marijuana.

Id
. at 3.

HHS further noted that “[a] clinical study involving marijuana should include certain core elements,” and that “[a] study that incorporates the [1997] NIH Workshop recommendations will be expected to yield useful data and therefore, will be more likely to receive marijuana under the HHS program.”
Id
.

Finally, HHS explained that the “proposed protocols must be determined to be acceptable under FDA's standards for authorizing the clinical study of investigational new drugs.”
Id
. Relatedly, HHS stated that “although FDA's review of Phase 1 submissions will focus on assessing the safety of Phase 1 investigations, FDA's review of Phases 2 & 3 submissions will also include an assessment of the scientific quality of the clinical investigations and the likelihood that the investigations will yield data capable of meeting statutory standards for marketing approval.”
Id
. HHS further made clear that if a protocol is approved, “NIDA will provide the researcher with authorization to reference NIDA's marijuana Drug Master File.”
Id
. at 4.

At the administrative hearing in this case, Steven Gust, Ph.D., Special Assistant to the Director of NIDA, explained that, in addition to seeking to facilitate research into the possible medical utility of marijuana, the new procedures implemented by HHS in 1999 were intended “to make the process more standardized, and to * * * provide some expertise that did not really exist at NIDA in terms of reviewing applications that involved * * * the use of marijuana * * * for treatment of diseases.” Tr. 1632-33. Accordingly, HHS “established a separate peer review process that * * * moved the review into the Public Health Service [a component of HHS] * * * where additional expertise from other NIH Institutes and other Federal agencies” could be utilized in reviewing the scientific merit of the applications.
Id
. at 1633-34. Dr. Gust further explained that the members of the review committee are drawn from the various specialty institutes of NIH, and the Substance Abuse and Mental Health Services Administration (SAMHSA).
Id
. at 1692; 1713-15.
15

Dr. Gust also testified that the “scientific bar has been set very low, [so] that any project that has scientific merit is approved,” and that “anything that gets approved gets NIDA marijuana.”
Id
. at 1700-01. As of April 2004, HHS had approved at least seventeen pre-clinical or clinical studies of marijuana, which were sponsored by the California Center for Medical Cannabis Research (CMCR).
16

GX 31, at

3. According to one witness who testified on behalf of Respondent, all of the CMCR-sponsored researchers who applied to NIDA for marijuana did in fact receive marijuana from NIDA. Tr. 694-95.

15
Dr. Gust initially testified that someone from FDA sits on the committee but later stated that he was not exactly sure if this was so. Tr. 1712.

16
The California research studies were conducted pursuant to a law enacted by California in 1999 known as the Marijuana Research Act of 1999. Cal.

Health & Safety Code § 11362.9. This state law established the “California Marijuana Research Program” to develop and conduct studies on the potential medical utility of marijuana.
Id.
(The program is also referred to as the “Center for Medicinal Cannabis Research” (CMCR). Tr. 396.) The state legislature appropriated a total of $9 million for the marijuana research studies. Tr. 397. The state law was enacted following the passage of Proposition 215, a ballot initiative otherwise known as the Compassionate Use Act of 1996. Tr. 395-96;
see also United States
v.
Oakland Cannabis Buyers' Cooperative
(“
OCBC
”), 532 U.S. 483, 486 (2001).

Respondent's Application and Contentions

Respondent is a Professor in the Department of Plant, Soil and Insect Sciences at the University of Massachusetts Amherst. Tr. 13. On June 28, 2001, Respondent submitted an application to bulk manufacture the schedule I controlled substances marijuana and tetrahydrocannabinols.
17

GXs 1 & 3; 21 CFR 1308.11(d). Respondent's application is sponsored by the Multidisciplinary Associations for Psychedelic Studies (MAPS). GX 3, at 1.

Because Respondent seeks a registration to manufacture a schedule I controlled substance, DEA required that he complete a questionnaire.
18

In response to the question regarding the purpose for which he sought registration, Respondent stated that “[t]he plant material will be grown for federally-approved uses only, including analytical, pre-clinical, and clinical research,” and that “no material is intended for illegal use or for medical marijuana patients whose use may be legal under state, but not federal law.” GX 3, at 1.
19

17
On his application for registration (GX 1), Respondent incorrectly checked the box for “dosage form” manufacturing when, in fact (based on the activity in which he proposes to engage), he is seeking to become registered as a “bulk” manufacturer. In written questions DEA submitted to Respondent as a follow-up to the application, DEA properly characterized the activity as “bulk manufacture,” and Respondent, in his written answers to these questions, gave no indication that he disagreed.
See
GX 3. Also, in his testimony at the hearing, Respondent acknowledged that his plan was to send marijuana “in bulk” to others, who would roll it into cigarettes. Tr. at 243. Respondent also testified that MAPS President Rick Doblin “assisted in the response to the
bulk
manufacturer's questions.” Tr. 352 (emphasis added). Cf. 32 CFR 1300.02(b)(32) (defining “drug product” as “an active ingredient in dosage form that has been approved or otherwise may be lawfully marketed under the Food, Drug, and Cosmetic Act for distribution in the United States”); 21 CFR 1301.72(a) & 1304.22(a) (listing “bulk materials awaiting further processing” separately from “finished products”).

18
As set forth in 21 CFR 1301.15: “The Administrator may require an applicant to submit such documents or written statements of fact relevant to the application as he/she deems necessary to determine whether the application should be granted.”

19
Respondent further testified that it was his intention to simply send bulk marijuana to researchers who would then roll their own cigarettes. Tr. at 243.

Respondent added that “[t]he production costs * * * would be underwritten by a grant” from MAPS.
Id
. According to Respondent, “MAPS is seeking to develop the marijuana plant into an FDA-approved prescription medicine,” and that “[t]he growth of plants at [UMASS] is a necessary step for supplying quality marijuana for use in MAPS' drug development process.”
Id
. Respondent also advised that “MAPS will sponsor research at other institutions using smoked marijuana and marijuana delivered through a vaporizer device that heats, but does not burn the plant material, thus reducing the products of combustion normally found in smoked marijuana.”
Id
.

Respondent further stated that his “[c]ustomers would include both MAPS-sponsored research and research sponsored by other organizations.”
Id
. at 3. Relatedly, Respondent explained that “[r]esearchers conducting MAPS sponsored research would receive supplies of the plant material free, while other researchers would either receive the marijuana free or through a donation to MAPS.”
Id
. at 1.
See also
Tr. 225 (“I may very well be approached by other people with approved studies who need a source also.”).

At the hearing, Mr. Rick Doblin, the President of MAPS,
20

also testified regarding the purpose of Respondent's application. Mr. Doblin, who admitted that he engages in recreational use of marijuana on a weekly basis, explained that “[t]he reason we need a supply from Dr. Craker is that we are engaged in trying to make marijuana into an FDA-approved prescription medicine, and * * * we need to establish a drug master file for a particular product, and * * * we need to conduct research with that product, and have that product available to us for potential marketing should we get FDA approval.” Tr. 603, 718-19. Mr. Doblin testified as to his “belie[f] that smoked marijuana or vaporized marijuana in plant form will successfully compete with marijuana extracts on price.”
Id
. at 605. He also testified as to his belief that the “efficacy and safety” of vaporized plant-form marijuana “will be similar” to drugs containing cannabinoid extracts and that “the efficacy will be similar and safety slightly different with smoked” marijuana than with drugs containing cannabinoid extracts.
Id
.

Mr. Doblin further testified that he “disagree[d]” with the Institute of Medicine's conclusion that defined and purified cannabinoid compounds “are preferable to plant products, which are of variable and uncertain composition.”
Id
. at 654. Mr. Doblin also testified that “what we're trying to do is get the Public Health Service and NIDA out of the picture; they're only in the picture just for marijuana only because they have a monopoly. And that is what is so obstructing the system.”
Id
. at 666.

20
When asked during the hearing about the title of his organization (Multidisciplinary Association for Psychedelic Studies) and, in particular the term “Psychedelic,” Mr. Doblin explained, in part, “it's about tools and procedures that bring to the surface people's subconscious and unconscious and, you know, deeper emotions.” Tr. 474.

Finally, Mr. Doblin testified that MAPS would only need between $5 to $10 million “to make marijuana into a medicine” through the various stages of the FDA new drug approval (NDA) process.
21

Id
. at 701;
see also id
. at 703. In his testimony, Mr. Doblin did not, however, identify a single instance in which an entity (whether for-profit or nonprofit) had taken a drug—let alone a botanical substance with known safety issues,
See
,
e.g.
, GX 43, at 9—through the multi-faceted NDA process for a similar cost.
22

Moreover, while Mr.

Doblin testified that “the mission statement [of MAPS] is to develop psychedelics and marijuana into FDA-approved medicines and then to educate the public about that” (Tr. 478), the vagaries of his testimony prevent a clear determination of how far along in that goal he envisions MAPS to be.
23

21
In a recent Supreme Court decision, Justice Ginsberg, in a dissenting opinion, summarized the process by which FDA approves new drugs for marketing as follows:

The process for approving a new drug begins with preclinical laboratory and animal testing. The sponsor of the new drug then submits an investigational new drug application seeking FDA approval to test the drug on humans.
See
21 U.S.C. 355(i); 21 CFR 312.1
et seq.
(2007). Clinical trials generally proceed in three phases involving successively larger groups of patients: 20 to 80 subjects in phase I; no more than several hundred subjects in phase II; and several hundred to several thousand subjects in phase III. 21 CFR 312.21. After completing the clinical trials, the sponsor files a new drug application containing,
inter alia
, “full reports of investigations” showing whether the “drug is safe for use and * * * effective”; the drug's composition; a description of the drug's manufacturing, processing, and packaging; and the proposed labeling for the drug. 21 U.S.C. 355(b)(1).

Riegel
v.
Medtronic, Inc.
, 128 S.Ct. 999, 1018-19 n.15 (2008) (Ginsburg, J., dissenting).

22
While Respondent produced evidence establishing that the $800-880 million costs of bringing a new drug to market includes research and development costs incurred for drugs that are not approved, as well as opportunity costs (the cost of investing in research rather than something else),
see
Tr. 161, 734-36, Respondent has not shown a single instance in which an entity has obtained FDA approval of a drug through the NDA process for the cost range which Mr. Doblin claimed would be sufficient to obtain approval of plant-form marijuana.

Moreover, the IOM Report states that the average cost of a Supplemental New Drug Application (SNDA), which is used when a company seeks to obtain FDA approval to market a drug (which has already gone through the three phases of clinical

trials and been approved for marketing) for a new indication, was $10 to 40 million. RX 1, at 214. It should be noted, however, that in taking a drug through the three phases, its sponsor will have obtained extensive data regarding the drug's safety including “adverse effects of the drug [and] clinically significant drug/drug interactions.” 21 CFR 314.50(d)(5)(vi).

In support of his assertion that MAPS could obtain FDA approval for only $5 to $10 million, Mr. Doblin testified that marijuana is different than other drugs that go through the FDA approval process. Mr. Doblin based this assertion on his contentions that: marijuana has been used by “tens of millions of people” while others drugs going though the NDA process are only used by a few thousand; there is “an enormous body of evidence about [marijuana's] safety * * * that we don't need to replicate;” and sufficient data to satisfy the FDA as to marijuana's safety and efficacy could be obtained by testing only 500 to 600 people.
Id
. at 737-38.

The FDA's guidance document for botanical drug products makes plain that “[a] botanical drug product that is not generally recognized as safe and effective for its therapeutic claims is considered a new drug under § 201(p) of the [Food, Drug, and Cosmetic] Act,[]” and that “any person wishing to market a botanical drug product that is a new drug is required to obtain FDA approval of an NDA * * * for that product.” GX 92A, at 7. Moreover, “an NDA must contain substantial evidence of effectiveness derived from adequate and well-controlled clinical studies, evidence of safety, and adequate CMC [chemistry, manufacturing, and controls] information.”
Id
.
See also
GX 92A, at 27-38 (specifying the information that must be provided to FDA for phase 3 clinical studies of a botanical product to meet the requirements of the FDA regulations governing the contents of INDs). Finally, with respect to the nonclinical safety assessment required to support phase 3 clinical trials, the FDA guidance states:

To support safety for expanded clinical studies or to support marketing approval of a botanical drug product, toxicity data from standard toxicology studies in animals may be needed * * * . A botanical product submitted for marketing approval as a drug will be treated like any other new drug under development. Safety data from previous clinical trials conducted in foreign countries will be considered in determining the need for nonclinical studies. However, previous human experience may be insufficient to demonstrate the safety of a botanical product, especially when it is indicated for chronic therapy. Systematic toxicological evaluations could be needed to supplement available knowledge on the general toxicity, teratogenicity, mutagenecity, and carcinogenicity of the final drug product.

Id
. at 34. While Mr. Doblin asserted that MAPS would not “need to replicate all those studies about the genetics, * * * the effect on reproduction, the effect in all sorts of bodily systems,” Tr. 737, he did not identify any specific studies performed in other countries that establish the safety of marijuana for testing in phase 3 clinical studies. While millions of people have undoubtedly used marijuana, few have done so subject to the scientific rigor of a controlled clinical trial. Nor did Respondent produce any credible evidence establishing that the various types of animal studies which FDA usually requires to support phase 3 clinical trials would not have to be performed. GX 92A, at 35-37.

23
As indicated above, based on the record, no clinical trials involving marijuana have advanced beyond phase 1. Moreover, each sponsor must submit to FDA his/her own IND to be authorized to conduct clinical investigation with a new drug (such as marijuana).
See
21 CFR 312.20, 312.23. Again, given the vagaries of Mr. Doblin's testimony, it cannot be determined whether there is sufficient existing preclinical laboratory and animal studies data to support a submission of an IND for whatever proposed indications that Mr. Doblin has in mind for his envisioned FDA-approved marijuana medicine. But even assuming,
arguendo
, that MAPS could successfully submit an IND based on existing data, it would still have to proceed through extensive clinical trials (
see
21 CFR 312.21), and then—assuming that such trials are fully successful at demonstrating the basis for safety and efficacy (which often is not the case with clinical trials)—MAPS would still have to submit and obtain approval of an NDA. All of these steps, and the uncertainties as to the outcomes of each step, further call into question Mr. Doblin's estimate of being able to obtain FDA approval of marijuana for only $5 to $10 million.

Correspondence Pertaining to the Application

Subsequent to Respondent's submission of his application for a DEA registration, on March 4, 2003, the Chief of DEA's Drug and Chemical Evaluation Section wrote to Respondent noting that “it appears that the basis for your application is the purported need for a higher potency and higher 'quality' marijuana product than that currently available from the National Institute on Drug Abuse.” GX 29, at 1. The DEA letter further explained that the Agency had “contacted NIDA, the Department of Health and Human Services * * * and some current researchers” and had “determined that * * * the quality of marijuana available from NIDA is acceptable,” that a high potency product with a THC content of 7 to 8 percent was currently “available to bona fide research protocols,” and that if “[i]n the future, should federally approved research protocols require a higher potency marijuana (
i.e.
15 percent THC), all believe that it could be supplied by NIDA.”
Id
.

Thereafter, on June 2, 2003, Respondent wrote to DEA acknowledging that during a visit with several agency Diversion Investigators, the discussion had “primarily focused[ed] on the need for an alternative source of plant material to that grown at the University of Mississippi under contract to the National Institute of Drug Abuse (NIDA).” GX 30. Continuing, Respondent stated that “[a] second source of plant material is needed to facilitate privately-funded, FDA-approved research into medical uses of marijuana, ensuring a choice of sources and an adequate supply of quality, research-grade marijuana for medicinal applications.”
Id
. Consistent with these statements, Respondent has declined to bid on the NIDA contract. Tr. 252-53.

Respondent further asserted that while “the primary researchers now receiving plant material may openly state to you that they are satisfied with the current source, * * * in private conversations these same researchers indicate a fear of having the current supply eliminated if they complain about the available source material.” GX 30. As support for his contention regarding the level of researcher's satisfaction with NIDA's marijuana, Respondent attached two items: a reprint of a newspaper article and a letter from a Dr. Ethan Russo to the then-Chief of DEA's Drug and Chemical Evaluation Section.
See
GX 30a & 30b.

At the hearing, Respondent testified that at the time he filed his application, he had become concerned, based on conversations he had with “other people,” that the marijuana provided by the National Center “may have been of relatively low quality, and that [it] was not readily available to run the clinical trials which some people wanted to run.” Tr. 215. When asked to provide the names of these “other people” who had told him this, Respondent said he did not recall.
Id
.

Respondent's Contentions Regarding the Inadequacy of NIDA Marijuana

Respondent makes three principal claims in support of his contention that the supply of marijuana currently available through NIDA is inadequate. First, he claims that “NIDA does not provide medical marijuana to all legitimate researchers” and that “NIDA has refused to provide marijuana to at least three legitimate researchers.” Resp. Prop. Findings at 12. Second, he claims that “the quality of the NIDA marijuana raises concerns for researchers and patients.”
Id.
at 16. Third, he claims that “the NIDA supply was inadequate because a pharmaceutical developer could not reasonably rely on NIDA marijuana to take marijuana through the FDA new drug approval process.” Respondent's Response to Govt.'s Exceptions (hereafter, “Respondent's Resp.”) at 16.

HHS's Denials of Researcher's Requests for NIDA Marijuana

Respondent's first claim is based on three incidents over a decade-long time period in which he alleges that researchers were improperly denied access to NIDA's marijuana. The first incident, which occurred in 1995, involved an application submitted by Donald Abrams, M.D., who sought

marijuana from NIDA to study its effects on persons with HIV-related wasting syndrome. RX 15, at 1. NIDA rejected Dr. Abrams's application “based upon issues of design, scientific merit and rationale.”
24

Dr. Abrams subsequently submitted a revised research protocol that NIDA found to be scientifically meritorious and for which NIDA supplied marijuana in 1997.
25

See
GX 21, at 1. NIDA also supplied Dr. Abrams with marijuana for subsequent studies.
Id.;
Tr. 689. In any event, for purposes of determining the relevance of the 1995 incident in which Dr. Abrams' original protocol was rejected by NIDA, it is notable that this occurred before HHS adopted its new guidelines for the provision of marijuana for research purposes. As Dr. Gust testified, in 1995, HHS's practice was to provide marijuana only to researchers who obtained NIH funding—a practice that was abandoned by HHS in 1999 when the agency adopted its new procedures for facilitating marijuana research (allowing privately funded researchers to also obtain marijuana). Tr. 1749.

24
That the above-quoted grounds were the bases upon which NIDA denied Dr. Abrams' original application is implicit from the letter that Dr. Abrams submitted to NIDA in response to the denial (RX 15). These bases are explicitly stated in NIDA's April 19, 1995, letter to Dr. Abrams, which appears on MAPS' Web site (at
http://www.maps.org/mmj/leshner.html
) and of which I take official notice. This letter from NIDA stated, among other things, the following:

Our decision here is based upon issues of design, scientific merit and rationale. We believe that your study will not adequately answer the question posed.

Although the study propose[d] seeks to make a dose-effect comparison of smoked marijuana to delta-9-tetrahydrocannabinol (THC), there is no real dosing control. The marijuana is to be taken home and there is no requirement and way to ensure that the subjects smoke all available materials on any fixed schedule. Additionally, that they are given a two-week supply of marijuana at one time further confounds the study design. Thus, we believe the dose-effect component is confounded since the study cannot correlate variability in weight gain with dosage.

We also believe the study lacks adequate sample size to make any inferences regarding the dose-effect relationship. . . . Another confounding variable not adequately controlled for in your proposed study is diet. Neither the total daily caloric intake nor the percentages of the composition of the foodstuffs is assessed.

In accordance with the Administrative Procedure Act (APA), an agency “may take official notice of facts at any stage in a proceeding—even in the final decision.” U.S. Dept. of Justice,
Attorney General's Manual on the Administrative Procedure Act
80 (1947) (Wm. W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and DEA's regulations, Respondent is “entitled on timely request to an opportunity to show to the contrary.” 5 U.S.C. 556(e);
see also
21 CFR 1316.59(e). To allow Respondent the opportunity to refute the facts of which I take official notice, Respondent may file a motion for reconsideration within fifteen days of service of this order which shall commence with the mailing of the order.

25
Following the 1996 passage of proposition 215, NIDA contacted Dr. Abrams and asked him if he would redesign his study to determine whether marijuana usage by persons who were HIV-positive (but who did not have AIDS-wasting syndrome) increased viral load as well as the interaction of marijuana with protease inhibitors. Tr. 523-24. Dr. Abrams agreed to do so and NIDA provided him with a $1 million grant to fund the study.

The second incident involved an application by Dr. Ethan Russo, a neurologist, who sought funding from NIDA to study the use of marijuana to treat migraine headaches beginning around 1996. Tr. 527-28. The precise dates of the events related to Dr. Russo are somewhat unclear as Respondent presented these events through the testimony of Mr. Doblin. (Dr. Russo did not testify.)
Id.
Based on Mr. Doblin's testimony, it appears that during 1996-97, NIDA twice rejected Dr. Russo's protocol for reasons which are not clearly established by the record.
Id.
at 527, 691-92. However, according to Mr. Doblin, Dr. Russo conceded that, on both of these two occasions when NIDA rejected his protocol, NIDA's bases for doing so did include “some valid critiques.” Tr. 692. Mr. Doblin testified that Dr. Russo subsequently attempted for a third time to obtain marijuana from NIDA, but on this third occasion he decided not to seek government funding but to seek private funding to purchase the marijuana from NIDA.
Id.
at 692. According to Mr. Doblin, this third protocol submitted by Dr. Russo was approved by both the FDA and Dr. Russo's institutional review board, but NIDA again refused to supply marijuana.
Id.
at 692-93. When asked when this last denial by NIDA occurred, Mr. Doblin testified: “I think it was 1999.”
Id.
at 693.

As noted above, NIH announced on May 21, 1999, HHS's new procedures for making marijuana available to researchers. Bearing in mind that Respondent had the burden of proving any proposition of fact that he asserted in the hearing, 21 CFR 1301.44(a), nothing in Mr. Doblin's testimony, or any other evidence presented by Respondent, established that HHS denied Dr. Russo's request for marijuana under the new procedures implemented by the agency in 1999. Indeed, Respondent produced no evidence showing that HHS has denied marijuana to any clinical researcher with an FDA-approved protocol subsequent to the adoption of the 1999 guidelines.

The third incident involved an application by Chemic Laboratories (Chemic), which—at the request of Mr. Doblin—sought marijuana from NIDA in 2004
26

for a proposed study involving a device known as the “Volcano Vaporizer” (hereafter “Volcano”). RX 49 & 52B. To understand the nature and purpose of this proposed study, some earlier facts that were disclosed at the hearing need to be considered. According to Mr. Doblin's testimony, prior to this incident (
i.e.
, before Chemic applied to NIDA for marijuana in 2004), Mr. Doblin had devised an elaborate arrangement whereby Chemic received marijuana to conduct an earlier study with the Volcano using marijuana obtained outside of the HHS process and without the knowledge or approval of HHS or DEA. Specifically, Mr. Doblin admitted that he encouraged persons who obtained marijuana from “buyers’ clubs” in California as well as persons who obtained their marijuana from NIDA under HHS's “compassionate use program”
27

to anonymously send their marijuana to a DEA-registered drug testing laboratory so that MAPS could compare the potency of the “buyers’ clubs” marijuana with that supplied by NIDA.
28

Tr. 668-82. Acting at the behest of Mr. Doblin, once the drug testing laboratory completed its analysis of the marijuana it received through these sources, it delivered the “extra” marijuana to Chemic, so that Chemic could conduct testing on the Volcano.
Id.
Chemic did conduct such testing,
29

which was funded by MAPS and the California National Organization for the Reform of Marijuana Laws (CaNORML), and Chemic published its results in two reports, one of which was co-authored by CaNORML.
30

See id.

26
It appears from the record that Chemic initially applied to HHS for marijuana in 2003 but, at HHS's request, Chemic submitted a revised protocol, which HHS considered to be submitted in 2004.
See
GXs 49 & 52B.

27

See Kuromiya
v.
United States,
78 F.Supp.2d 367 (E.D. Pa. 1999) (describing compassionate use program under which less than 10 persons currently receive marijuana from HHS).

28
Because marijuana is a schedule I controlled substance, human use is limited to “Government-approved research” in accordance with 21 U.S.C. 823(f).
See OCBC,
532 U.S. at 491-492 and n.5. In accordance with § 823(f) and the DEA regulations, where a schedule I controlled substance is used in research—including the HHS compassionate use program—the activities involving the substance must be limited to those authorized in the research protocol.
See
21 CFR 1301.13(e)(1)(v), 1301.18. Research activities beyond those specified in the protocol are prohibited absent the submission and approval of a supplemental protocol. 21 CFR 1301.18(d). Respondent made no attempt to assert that any of the research protocols associated with the compassionate use program allow for the distribution of marijuana to a drug testing laboratory, as there is no basis for such an assertion. The CSA prohibits the distribution of any controlled substance except as authorized by the Act, 21 U.S.C. 841(a)(1), and the Act makes no allowance for ultimate users (including research subjects) to distribute their controlled substances to others.

29
Chemic was not registered with DEA under 21 U.S.C. 823(f) to conduct research with marijuana and when DEA later learned that Chemic was seeking to conduct a second marijuana study (when Chemic subsequently sought to obtain marijuana directly from NIDA and sought DEA's authorization for doing so), the agency so advised Chemic that this activity required a research registration.
See
RX 49, at 2. DEA registrants are only authorized to conduct activities with controlled substances “to

the extent authorized by their registration and in conformity with other provisions of [the CSA].” 21 U.S.C. 822(b).

30
The first report, which was submitted by Chemic in 2003 to MAPS and CaNORML, is titled “Evaluation of Volcano(r) Vaporizer for the Efficient Emission of THC, CBD, CBN and the Significant Reduction and/or Elimination of Polynuclear-Aromatic (PNA) Analytes Resultant of Pyrolisis,” and is available on MAPS' Web site at
http://www.maps.org/mmj/vaporizerstudy4.15.03.
The second report, titled “Cannabis Vaporizer Combines Efficient Delivery of THC with Effective Suppression of Pyrolitic Compounds,” also appears on MAPS' Web site at
http://www.maps.org/mmj/Gieringer-vaporizer.pdf.
I take official notice of both documents.
See also http://www.maps.org/news-letters/v13n1/13111gie.pdf
(2003 MAPS news letter discussing Vaporizer studies sponsored by MAPS and NORML and the Marijuana Policy Project), of which I take official notice.

Thus, this “third incident” to which Respondent points involved an effort by MAPS to expand upon the research that Chemic had conducted on the Volcano—this time using marijuana directly obtained from NIDA rather than using marijuana obtained without the knowledge or approval of HHS or DEA. Id. Under MAPS sponsorship and oversight, Chemic so applied to NIDA in 2004. Id.; RX 52B. The protocol submitted by Chemic proposed to heat marijuana obtained from NIDA and from a Dutch “medical marijuana” program to three different temperature levels below its combustion temperature and to then “compare the quality and relative percentage of available cannabinoids” in the material obtained from each source. RX 52B, at 2-3.

By letter dated July 27, 2005, a U.S. Public Health Service (PHS) committee of scientists, which evaluated Chemic's protocol pursuant to the 1999 Guidance, rejected it on the grounds that the “project does not add to the scientific knowledge base in a significant way.”
31

Id. at 4. With respect to the protocol's purpose of comparing the cannibinoid content of NIDA and Dutch marijuana, the PHS committee found that “[m]arijuana varies in THC content and [that] simply demonstrating that this device can measure those differences is of little scientific value.”
Id.
at 3. The PHS committee also found that the protocol's other purposes (“to conduct a reliability study of the device by analyzing multiple vapor collections” and to “determine the ‘precision, accuracy, robustness and efficacy' of the vaporizing device”) did “not appear to be a hypothesis driven research project,” but rather, “analogous to a process that is used to ‘validate’ an analytical method.”
Id.
The PHS committee thus concluded that the “overall aims of the project appear to be descriptions of work that would need to be conducted as part of good standard laboratory procedure prior to a clinical study.”
Id.

31
HHS also noted that there were “a number of technical concerns” with Chemic's proposal. RX 52B, at 4.

The PHS Committee further noted that, at that time (2005), a separate, HHS-approved clinical trial involving marijuana and the Volcano was already underway.
Id.
This then-ongoing clinical trial was being conducted by Dr. Abrams and was sponsored by the CMCR, using NIDA-supplied marijuana.
Id.
; Tr. 689. Moreover, as the letter from the PHS Committee indicates, one of the documents that Dr. Abrams had previously submitted in support of his then-ongoing clinical trial was a report that Chemic itself had prepared regarding its prior study of marijuana and the Volcano.
32

GX 52B, at 3. Given that Dr. Abrams' clinical trial was “underway and is examining the pharmacodynamics and pharmacokinetics of several different potencies of marijuana in human volunteers using the Volcano(c) device,” the Committee concluded that “[i]t is difficult to see what additional scientific knowledge will be provided by the current protocol, considering the prior work done by the applicant, as described in the above report, and the ongoing clinical trial at CMCR.”
Id.

32
The report, titled “Evaluation of Volcano® Vaporizer for the efficient emission of THC, CBD, CBN and the significant reduction and/or elimination of polynuclear-aromatic (PNA) analytes resultant of pyrolysis,” appears on MAPS Web site as discussed in note 30.

Respondent also introduced into evidence a letter from the President of Chemic to HHS responding to several points raised by the PHS Committee in denying Chemic's application.
See
RX 55. Respondent's letter does not, however, establish that HHS impermissibly denied Chemic's application for marijuana.
33

To the contrary, the evidence supports the conclusion that HHS (acting through the PHS Committee) made its determination not to supply marijuana on this occasion based on scientific considerations, finding that Chemic's then-latest proposed study was duplicative of prior and ongoing research and not likely to provide useful data.

33
If Chemic had a valid basis to challenge HHS's denial of its request for marijuana, it presumably had remedies available to challenge that agency action either within HHS or in the courts.
See, e.g.
, 5 U.S.C. 702 (“A person suffering legal wrong because of agency action * * * is entitled to judicial review thereof.”). Respondent produced no evidence showing that Chemic has pursued any such remedies.

Respondent's Contention That NIDA's Marijuana Is of Poor Quality

Respondent also contends that “[t]he quality of the NIDA marijuana raises concerns for researchers and patients.” Resp. Prop. Findings at 16. In this regard, Respondent asserts that various researchers have complained that NIDA's marijuana is of inconsistent potency, that NIDA's marijuana is harsh, that NIDA's marijuana is frequently several years old and not fresh, that the available product is of low potency, and that NIDA's product includes stems and seeds.
See id.
at 16-27. Contrary to Respondent's view, the evidence does not “demonstrate[] serious concerns about the quality of NIDA's” marijuana products.
Id.
at 27. As explained below, Respondent's contentions are largely based on snippets from questionnaires in which the researchers generally indicated their overall satisfaction with the quality of NIDA's marijuana. As the ALJ found, “a preponderance of the record establishes that the quality is generally adequate.” ALJ at 84.

With respect to the contention that NIDA's marijuana is of inconsistent potency or inadequate potency, Respondent relies on comments contained on three questionnaires that were completed by researchers at DEA's request. Resp. Prop. Findings at 17-18. One of the questions asked: “Have you ever had any difficulty obtaining marijuana from NIDA for all strengths of cigarettes to meet research requirements?” GX 16, at 8. While Dr. Grant of the CMCR answered affirmatively and added that “having consistency of 6% -8% [THC] content have been difficult,” he further stated that NIDA “ha[s] been
accommodating
by trying to produce the high % products in a timely manner.”
Id.
at 9 (emphasis in original). In response to another question regarding the adequacy of NIDA's products, Dr. Grant noted that “NIDA has been reliable[,]” and “they have been easy to work with and amenable to accommodating for the requirements of the study.”
Id.
at 6.

It is true that Dr. Grant, in answering this question, noted the problems with the range of potency in the higher potency material. Dr. Grant explained, however, that the problems he found regarding the range of potency were attributable to the cigarettes being “handrolled and thus difficult to prepare.”
Id.
Moreover, Dr. Grant answered “yes” to the question of whether NIDA's current products were “adequate for your research purposes

with regard to potency?”
Id
. at 15. Also, in response to the question of whether “these problems [have] ever compromised the study?,” Dr. Grant indicated: “N/A.”
Id
. at 6.

Dr. Grant further indicated that he had “no” information that “would lead [him] to believe that the future supply of marihuana required for research would be insufficient or unavailable through NIDA,”
id
. at 8, and that he had “no” concerns regarding “the availability of research-grade marijuana from NIDA” to meet CMCR's future needs.
Id
. at 9. While Dr. Grant also indicated that it would be clinically important to evaluate a higher potency product than the 7-8 percent THC content marijuana CMCR was currently using, he also indicated that CMCR had not sought a higher potency product but had only discussed with NIDA the feasibility of such a product.
Id
. at 16.

On his questionnaire, Ronald Ellis, M.D., of the University of California, San Diego, noted that in “[a]t least two shipments, [there] was some variability on stated THC content and the actual [content] measured.” GX 17, at 6. Dr. Ellis further noted, however, that NIDA personnel “have been very responsive.”
Id
. Apparently, Dr. Ellis's clinical trial received some marijuana which was supposed to have a THC content of 8 percent, but only had a content of approximately 7 percent.
Id
. at 9. Dr. Ellis indicated, however, that the potency of NIDA's current product was adequate for research purposes.
Id
.

Respondent also relies on Dr. Donald Abrams' “no” answer regarding the consistency of the potency of NIDA's product. Resp. Prop. Findings at 18 (citing GX 21, at 6). Dr. Abrams further noted that “[o]riginally approved for 3.9% THC content, midway through the ‘Short-term effects * * *’ protocol, NIDA informed [us] that the potency had been downgraded to 3.5%. Everything since is said to be at 3.5%.” GX 21, at 6. Notably, the “Short-term effects” study occurred more than a decade ago, and Dr. Abrams did not indicate that there had been further problems with the consistency of the potency of the marijuana supplied by NIDA for several later studies he conducted.

Nor does the evidence support Respondent's contention that the marijuana available through NIDA is of insufficient potency to satisfy the needs of legitimate researchers. In his brief, Respondent relies on the statements of Drs. Grant and Abrams that it would be beneficial to evaluate the efficacy of marijuana cigarettes with a higher THC content than what was currently being supplied by NIDA. Resp. Prop. Findings at 22-23 (citing GX 16 & 21). Respondent, however, produced no evidence establishing that any researcher has obtained approval of FDA and other reviewing authorities to conduct clinical trials using higher THC content marijuana. As Dr. Abrams explained, he “wanted to use a higher potency product but there were questions from the [scientific review board] and the funding agency [CMCR].” GX 21, at 9.

Moreover, as Dr. ElSohly testified, the National Center has in inventory substantial quantities of bulk marijuana material with THC contents of ten to eleven percent and has some material with a THC content of fourteen percent.
34

Tr. 1203. Dr. ElSohly also testified that the National Center could produce marijuana with a THC content of up to 20 percent.
Id
. He further testified that he had informed “some of the investigators that if they want to, they can order material of a certain potency” and “roll their own cigarettes.”
Id
. at 1204-05.

34
Respondent also cites the questionnaire of Prof. Aron Lichtman, of the Department of Pharmacology, Virginia Commonwealth University, who conducted research in animals. Resp. Proposed Findings at 23 (citing GX 28). On his questionnaire, Prof. Lichtman indicated that he “would [have] prefer[red] something at a higher potency, but at the time, 3-4% was the highest potency available.” GX 28, at 9. Prof. Lichtman's questionnaire indicated, however, that his study had last obtained marijuana in 1999. Prof. Lichtman's answer is thus not probative of whether NIDA is currently capable of providing marijuana of adequate potency to support legitimate research needs.

Respondent's evidence regarding the potency of marijuana distributed by NIDA for patients in the former Compassionate Investigational New Drug program likewise dates back to 1999. See Resp. Prop. Findings at 24 (citing RX 19, at 47-48). As such, the evidence is not probative of whether NIDA is currently capable of supplying marijuana of adequate potency.

Respondent also maintains that NIDA's marijuana is harsh and that some patients have complained that it was “inferior in sensory qualities (taste, harshness) [to] the marijuana they smoke outside the laboratory,” and that “it was the worst marijuana they had ever sampled.” Resp. Prop. Findings at 19-21. Yet, as the questionnaires completed by the researchers indicate, only a small percentage of study subjects have complained about the harshness of NIDA's marijuana. See GX 18, at 7 (one of ten patients complained); GX 21, at 8 (four out of fifty dropped out because of quality); GX 22, at 7 (“Out of 100 plus subjects, no more than [three] may have commented that the product was harsh.”).
35

Moreover, as one of the researchers noted, it was unclear whether the harshness was related to the actual marijuana cigarettes or the placebo material.
36

As for Respondent's further contention that some patients complained that NIDA's marijuana “was the worst they had ever sampled,” this evidence does not establish that the taste of the products rendered them unsuitable for their intended use.
37

Furthermore, Respondent provides no scientific basis for his suggestion that the research subjects' description of the degree of their subjective satisfaction with the experience of smoking marijuana in a research setting should be a criterion for judging the adequacy of the quality of marijuana for research purposes.
38

35
Dr. ElSohly testified: “I think you had like 50 subjects, and only three or four complained of the harshness. That's a very small percentage. You are going to get that regardless of what you administer.” Tr. at 1589.

36
As Dr. Cory-Bloom noted, it was unclear whether the harshness was attributable to actual marijuana cigarettes or placebo cigarettes. GX 18, at 7. Relatedly, Dr. ElSohly testified that the complaints of harshness were likely attributable to the placebo because “all of the components have been extracted out . . . [s]o this will be just like smoking * * * grass or * * * hay or something like that or just paper that might have this harshness, and there's no soothing effect of the other components in the plant material.” Tr. 1289-90.

37
Respondent also cites to hearsay evidence regarding the experience of a single patient who had previously used non-NIDA marijuana (illegally obtained from California “buyers” clubs”) without problems but then purportedly developed bronchitis upon smoking NIDA marijuana. Resp. Prop. Findings at 21; Tr. 570. Even if I were to credit this testimony, the record as a whole establishes that NIDA's marijuana was well tolerated in the great majority of the various studies' subjects.

38
Marijuana is known to cause, among other things, “a distortion in the sense of time associated with deficits in short-term memory and learning,” “difficulty carrying on an intelligible conversation,” anxiety, paranoia, panic, depression, dysphoria, delusions, illusions, and hallucinations. RX 1 (IOM report), at 101-102. These effects impact the determination of what, if any, weight to attach to research subjects' descriptions of their satisfaction with the marijuana they have smoked.

Finally, Respondent contends that NIDA's marijuana is frequently “not fresh” and that it includes stems and seeds. Resp. Prop. Findings at 21-22; 25-27. While the record contains some evidence that older marijuana loses some if its potency, all but one of the researchers indicated that neither the lack of freshness nor the existence of plant parts (stems and seeds) had adversely impacted their research.
See
GX 16, at 13 (CMCR); GX 17, at 7 (Dr. Ellis); GX 18, at 7 (Dr. Corey-Bloom); GX 19, at 7 (Dr. Israelski);
39

GX 20, at 7 (Dr. Wallace); GX 22, at 7 (Dr. Polich); GX 28, at 7 (Prof. Lichtman);
but see
GX 21, at 7-8 (Dr. Abrams) (indicating that four

out of fifty patients had “dropped out due to quality”).

39
Dr. Israelski did not recall any complaints about the “freshness” of NIDA's marijuana.

Moreover, with respect to the existence of stems and seeds in NIDA's marijuana, Dr. ElSohly acknowledged that prior to 2001, there may have some stems and seeds in the marijuana it sent to the Research Triangle Institute (the contractor for the manufacture of the cigarettes). Tr. 1300-01. Dr. ElSohly further testified, however, that in 2001, the National Center acquired a special de-seeding machine which removes all the seeds and stems from the marijuana that is used to manufacture cigarettes.
Id
. at 1301. Respondent produced no evidence showing that the marijuana which the National Center has since supplied has contained stems and seeds.
40

40
In support of its contention that NIDA marijuana contains stems and seeds which renders the product's quality inadequate, Respondent also cites an article, “Chronic Cannabis Use in the Compassionate Investigational New Drug Program.” Resp. Prop. Findings at 26 (citing RX 19, at 49-50). Respondent particularly notes two photographs of marijuana that was manufactured in April 1999.
See id.
This evidence thus predates the National Center's 2001 acquisition of a de-seeding machine.

Respondent's Contention That NIDA's Marijuana Is Inadequate To Support The Development of Plant-Form Marijuana Into an FDA-Approved Prescription Drug

Respondent further contends that the existing supply of NIDA marijuana is inadequate because “MAPS seeks to develop botanical marijuana as an FDA-approved prescription drug.” Resp. Prop. Findings at 8. In support of this contention, Respondent makes two primary factual assertions. First, he claims that “to develop a pharmaceutical product, a developer must have assured access to a reliable, dependable source of the particular formulation of the product the developer needs, both for research, and for distribution if the product is approved,” and that “[w]ithout such a source, there is no development.”
Id.
at 9. Second, he claims that “even before the Phase [1] and Phase [2] studies on a product, the developer must generally submit a Drug Master File,”
41

and that the Drug Master File (DMF) for NIDA's marijuana contains proprietary information which NIDA controls.
Id.

41
I also take official notice of the FDA's
Guideline For Drug Master Files
(Sept. 1989) (available at
http://www.fda.gov/cder/guidance/dmf.htm/
).

According to this FDA guideline (at 2), “[a] Drug Master File (DMF) is a submission to the [FDA] that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.”

As for Respondent's contentions regarding the need to submit a DMF, Respondent asserts that “there is no procedure to force [the DMF's] owner to make a Drug Master File, or the information in it, available to a drug developer.” Resp. Prop. Findings at 10 (citing Tr. 447-49; testimony of Dale Gieringer). While Respondent concedes that NIDA “has allowed the researchers whom it chooses to supply with marijuana to rely on that file,” and that FDA has approved several Phase 1 studies using NIDA marijuana and the information contained in the DMF,
id.
at 10, it contends that because NIDA's mission is to study drug abuse, it is not likely that “NIDA would authorize MAPS to rely on the NIDA marijuana [DMF] currently on file with the FDA.”
Id.
at 45.

The 1999 HHS Guidance makes clear, however, that if a proposed research project meets the Department's criteria for the provision of research-grade marijuana, “NIDA will provide the researcher with authorization to reference NIDA's marijuana Drug Master File.” GX 24, at 4. Moreover, as the FDA has explained, “the submission of a DMF is not required by law or regulation,” but rather, “is submitted solely at the discretion of the holder.”
Guideline For Master Drug Files
, at 2. The FDA regulations provide: “FDA ordinarily neither independently reviews drug master files nor approves or disapproves submissions to a drug master file. Instead, the agency customarily reviews the information only in the context of an application under part 312 or part [314].” 21 CFR 314.420(a). Accordingly, as the FDA Guidelines explain, while “the information contained in [a] DMF may be used to support an Investigational New Drug Application (IND), [or] a New Drug application (NDA) * * * [a] DMF is NOT a substitute for an IND [or] NDA.”
Guideline For Master Drug Files,
at 3.

Relatedly, David Auslander, M.D., the Government's expert witness in pharmaceutical development, testified that “not all companies do Drug Master Files” and that “FDA does not necessarily require a Drug Master File to do a Phase [1] and Phase [2] study in all cases if the Drug Master File * * * comes from a producer that's different from the sponsor itself.” Tr. 2024. Dr. Auslander also explained that a drug developer may not even have a Drug Master File at the time it applies to conduct Phase 1 or Phase 2 studies.
Id.
As Dr. Auslander further testified, the necessary information can be submitted in an IND or an NDA.
Id.
at 2024-25.

As for the contention that NIDA is not a reliable source of supply, it is undisputed that a for-profit drug developer would be unlikely to take a drug through the FDA approval process unless it was “assured that they would have a drug supply that is unchanging and reliable.” Tr. 117 (testimony of Irwin Martin, Ph.D.). Dr. Martin also testified that “[o]ne of the biggest problems in drug development is the unfortunate need sometimes to repeat studies. If you have a new formulation or your drug source has changed, you many need to repeat years worth of data because you can no longer assure that the data you developed with this earlier version of [the] drug will actually be the same drug as you now have.”
Id.
at 118. Dr. Martin further testified that while “no reasonably business-oriented company would ever develop a product” if it did not have a reliable and consistent supply source, he also noted that if a company had to change its supply source, a company could try to show that the new product was pharmcokinetically equivalent to the old product. Tr. 120-21;
see also
Tr. 2027.

Also on this issue, Dr. Auslander testified further on behalf of the Government that if the developer's source changed, it “would not necessarily repeat the Phase [1] and [2] clinical studies over again, but * * * would do additional chemical studies, stability [studies] * * * to show that the quality of material from source A and the quality of material acquired from source B are equivalent.” Tr. 2027-28. Both Respondent's and the Government's experts agreed, however, that if the developer could not establish equivalence between the two products, “it would not be a trivial experience” for the developer.
Id.
at 2029;
see also id.
at 121 (testimony of Dr. Martin that developer would have to start over).

Relatedly, Respondent further asserts that there is “overwhelming” evidence that NIDA “would not be likely to choose to serve as the supplier to a medical marijuana pharmaceutical product developer even if it were authorized to so.” Resp. Prop. Findings at 10. In support of this assertion, Respondent extracts two sentences from a letter in which Nora Volkow, M.D., NIDA's director, responded to Mr. Doblin's letter accusing NIDA/HHS of “seriously obstructing” Chemic's research involving the Volcano which MAPS was sponsoring (and whose application HHS ultimately denied).
42

See id
. (quoting RX 13; “It is

not NIDA's role to set policy in this area or to contribute to the DEA licensing procedures. Moreover, it is also not NIDA's mission to study the medicinal use of marijuana or to advocate for the establishment of facilities to support this research.”).
See also
RX 14 (letter of Mr. Doblin; “NIDA/HHS is seriously obstructing a privately-funded drug development program aimed at evaluating marijuana's potential use as an FDA-approved medication.”).

42
In that letter, Mr. Doblin also mentioned that DEA had indicated that it would not review Chemic's application to import ten grams of Dutch marijuana until NIDA/HHS completed its review of Chemic's protocol. RX 14. Mr. Doblin also

referenced DEA's handling of Respondent's application.

In that letter, Dr. Volkow declined to intervene explaining that:

* * * NIDA is just one of the participants on the HHS review panel and continues, on behalf of the U.S. Government, to provide supplies of well-characterized cannabis for both NIH and non-NIH-funded research. The latter is conducted according to the procedure established in 1999 by HHS for obtaining access to marijuana for research purposes. It is not NIDA's role to set policy in this area or to contribute to the DEA licensing procedures. Moreover, it is not NIDA's mission to study the medicinal uses of marijuana or to advocate for the establishment of facilities to support this research. Therefore, I am sorry but I do not believe that we can be of help to you in resolving these concerns.

RX 13. As both this letter and the 1999 Guidance make plain, HHS—and not NIDA—is the policymaker regarding the criteria for determining who can obtain research-grade marijuana from NIDA. As NIDA does not independently control to whom it may supply marijuana for legitimate research, the letter is not indicative of whether NIDA would be a reliable source of marijuana for an entity which sought to develop plant-form marijuana into an FDA-approved prescription medicine.

Respondent also points to the 1999 Guidance document's statement that “[t]he goal of this program must be to determine whether cannabinoid components of marijuana administered through an alternative delivery system can meet the standards enumerated under the Federal Food, Drug, and Cosmetic Act for commercial marketing of a medical product. As the IOM report stated, 'Therefore, the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug, but such trials could be a first step towards the development of rapid-onset, nonsmoked cannabinoid delivery systems.’ ”
43

GX 24, at 2.

43
In discussing the content of the HHS Guidance, Respondent asserts: “And it expressly states that ‘the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug.’ ” Resp. Proposed Findings at 11 (quoting GX 24, at 2). Notably, Respondent's quotation edits out the Guideline's reference to the IOM Report. The complete text of the Guidance shows, however, HHS did not come to this conclusion without evidentiary support, but rather, relied on the extensive findings of the IOM.

As found above, the IOM's recommendation was based on its conclusion that “[a]lthough marijuana smoke delivers THC and other cannabinoids to the body, it also delivers harmful substances, including most of those found in tobacco smoke. In addition, plants contain a variable mixture of biologically active compounds and cannot be expected to provide a precisely defined drug effect. For those reasons there is little future in smoked marijuana as a medically approved medication.” RX 1, at 195-96.

Moreover, the HHS Guidance does not address what the Secretary's response would be were the current clinical trials to show that the efficacy/safety profile of smoked marijuana supported FDA approval of it as a prescription medicine for particular indications or patient populations. Nor does it address what the Secretary's response would be if clinical trials were to show that the efficacy/safety of vaporized plant form marijuana for particular indications supported its approval as a prescription drug.

Dr. Gust testified that notwithstanding the stated goal of the 1999 Guidance, a researcher who “had an IND from FDA * * * would not have a problem getting marijuana.” Tr. 1718. Further, in response to the ALJ's question as to whether a researcher whose goal was to obtain FDA approval of plant-form marijuana would have more difficulty obtaining marijuana from HHS than a researcher who sought to produce an extract-based product, Dr. Gust testified: “I don't believe so.”
Id.
at 1719-20.

Dr. Gust also explained that whether plant-form marijuana should be approved as a prescription medicine is “not a question for the” PHS committee that reviews requests for NIDA marijuana.
Id.
at 1720. Rather, “it's a question for the regulation and approval process that goes on through FDA.”
Id.
Finally, while Dr. Gust acknowledged that “HHS would strongly endorse” the IOM's view that “if there's going to be an approved medication, it's going to be a purified constituent of marijuana that will be delivered in a non-smokable form,” he further testified that in his experience, there was no bias against “the concept of approving marijuana as a medication” at the level of PHS review.
Id.
at 1722.
44

44
In discussing this testimony, the ALJ noted that Dr. Gust had acknowledged that a researcher with an FDA-approved protocol might nonetheless be denied marijuana by the PHS committee under the criteria set forth in the guidance. ALJ at 51 (citing Tr. 1694). There is, of course, no evidence that any researcher with an FDA-approved protocol has been denied marijuana subsequent to the 1999 guidelines. Dr. Gust's answer was based on a hypothetical question. Accordingly, this portion of Dr. Gust's testimony provides no basis to question his credibility as to whether in his experience, HHS (and the PHS review committees) are biased against researchers who seek to obtain FDA approval for plant-form marijuana.

Respondent further asserts that “it is not at all clear that NIDA
could
serve as a source for a pharmaceutical product.” Resp. Prop. Findings at 11 (emphasis in original). Notwithstanding Mr. Doblin's beliefs regarding the likely safety/efficacy profiles of smoked and vaporized marijuana,
see
Tr. at 605, it is highly speculative whether clinical trials will ultimately support FDA approval of plant-form marijuana through either delivery system.
45

45
Given that, as indicated above, marijuana has been found to contain hundreds of different chemicals, including a variable mixture of biologically active compounds that cannot be expected to provide a precisely defined drug effect, IOM has expressed the view that, “if there is any future in cannabinoid drugs, it lies with agents of more certain, not less certain, composition.” RX 1, at 195-96.

As further support for this contention, Respondent references that Dr. ElSohly answered “That's correct” when asked the following question by Respondent's counsel: “So if somebody wants to develop a commercial product with marijuana, they could not use the NIDA marijuana; is that fair?” Resp. Prop. Findings at 11 (quoting Tr. 1463). It is not clear exactly what to make of Dr. ElSohly's answer to this question.
46

In

any event, no provision of the National Center's contract with NIDA imposes any prohibition on the use of the marijuana produced under the contract for the purposes of the development of a commercial product. Indeed, the language of the contract with NIDA suggests otherwise. While Article H.13 states that “contract funds shall not be used to support activities that promote the legalization of any drug or other substance included in schedule I” of the CSA, it further provides that “[t]his limitation shall not apply when the contractor makes known to the contracting officer that there is significant medical evidence of a therapeutic advantage to the use of such drug or other substance or that federally sponsored clinical trials are being conducted to determine therapeutic advantage.” GX 13, at 20 (citing Pub. L. 108-447, § 510, 108 Stat. 2809 (2005)). Likewise, the new procedures that HHS announced in 1999 for providing marijuana for medical research contain no restriction on using NIDA-supplied marijuana for the development of commercial products. GX 24. To the contrary, by adopting a new procedure whereby privately funded researchers could obtain marijuana from NIDA at cost, HHS made it possible starting in 1999 for a commercially sponsored researcher to develop a drug product using NIDA-supplied marijuana.
See id.
at 2. Finally, Respondent cites no provision of law that prohibits NIDA from serving as a supply source for a prescription drug approval process.
47

46
Based on the questions that led up to the above-quoted question, it appears that, in answering “That's correct,” Dr. ElSohly was confirming that the marijuana he grows pursuant to the NIDA contract may not be taken by the University of Mississippi (without prior authorization from NIDA) for use in the commercial development of a THC extract product where such commercial activity was not authorized by NIDA.
See
Tr. at 1462-63. Indeed, the following subsequent exchange between Respondent's counsel and Dr. ElSohly suggests that Dr. ElSohly correctly understood that there was no prohibition on the use of NIDA marijuana for the development of commercial products:

Q: Dr. ElSohly, if an organization like MAPS, for example, a nonprofit or pharmaceutical organization, wanted to try to develop smoked marijuana into an FDA-approved medicine, could it use the marijuana that you grow to the preclinical and clinical testing if NIDA agreed?

A: I would say yes.

Tr. 1562-63. Moreover, even if Dr. ElSohly was of the mistaken view that the marijuana he grew for NIDA could never be used by anyone for commercial product development, such a misunderstanding on Dr. ElSohly's part would not be controlling for purposes of this proceeding. The record is clear that it is HHS—not Dr. ElSohly—that determines the terms of his contract, including to whom and under what circumstances he may supply marijuana; and the record is also clear that Dr. ElSohly follows the instructions he receives from NIDA as to whom to deliver the marijuana. Further, as explained above, the record reveals that HHS's policy contains no prohibition on the use of

the marijuana grown pursuant to the NIDA contract for commercial development purposes.

47
As for Respondent's contention that the Government did not “introduce any evidence that NIDA could or would [serve as a supply source] to support its claim that NIDA's supply is adequate to meet all legitimate medical and scientific purposes,” Resp. Prop. Findings at 11, Respondent, and not the Government, has the burden of proof on the issue of whether supply is inadequate within the meaning of 21 U.S.C. 823(a)(1).
See
21 CFR 1301.44(a).

Evidence Regarding the Remaining Statutory Factors

There is no evidence that Respondent has not complied with applicable state or local laws.
See
Gov. Proposed Findings at 139 (discussing 21 U.S.C. 823(a)(2)). Moreover, Respondent has never been convicted of any controlled-substance related offense. Tr. 78;
see
21 U.S.C. 823(a)(4).

As for factor five, on the questionnaire, Respondent acknowledged that he “has no current or previous registrations and is unaware of any registration [having] previously [been] granted to the university.” GX 3, at 3. While Respondent testified that he would meet all “appropriate security conditions,” he also acknowledged that “I've never grown marijuana or any other controlled substance.” Tr. 79. He further testified that “We have not—I have no experience in the control against diversion.”
Id.
Relatedly, Respondent testified that he had no personal experience in providing security for plants,
id
. at 255, and that both graduate students and technicians would be used to perform the various tasks associated with the project.
Id.
at 254 (“I usually don't go down and water the plants in the greenhouse; I usually have a technician that does that.”);
id.
at 254-55 (“They [the graduate students and technicians] would probably do the transplanting[,]” and “a daily check on any environmental controls we have.”). Respondent presented no evidence that any person who would be involved in the daily operation of the project would have experience in the lawful manufacture or distribution of schedule I and II controlled substances.
48

48
Respondent testified that he had performed classified work on plants for the U.S. Army and that “there were security systems in place similar to the security systems you have in this building” (referring to DEA Headquarters, where the hearing took place), and he answered “Yes” when asked by his counsel whether he recognized “the importance of that sort of security in a situation like this registration application.” Tr. 367. It is unclear what Respondent meant by “the security systems you have in this building,” since the only security to which he would have been exposed in entering DEA Headquarters to testify were the requirements of passing through a metal detector, being accompanied by a DEA employee, and wearing a visitor's badge. These DEA Headquarters security measures have nothing to do with the security measures required of DEA registrants who handle controlled substances, which are set forth in 21 CFR 1301.71 through 1301.76. Thus, this portion of Respondent's testimony was ambiguous and did not establish, for purposes of 21 U.S.C. 823(a)(5) that, if his application were granted, there would exist in his establishment effective controls against diversion.

Finally, Respondent testified that he believed that granting his application would promote technical advances in the art of manufacturing controlled substances and the development of new substances.
Id
. at 74-76. More specifically, Respondent asserted that granting his application would advance “the understanding [of] any possible clinical use of marijuana if we were able to supply this to investigators to run trials.”
Id.
at 75-76. Respondent also testified that “we would learn more about how the environment affects the constituents in the plant material which would enable” a potential manufacturer, were marijuana to become approved by the FDA as a drug, to “know the environment it needs to be grown under to produce a clinical marijuana.”
Id.
at 76. Respondent further opined that granting his registration would promote technical advances because part of the purpose of growing the marijuana was to allow MAPS to test its vaporizer.
Id.
at 77-78. Respondent acknowledged, however, that he would not personally be working on MAPS's vaporizer device or on any other delivery device.
Id.
at 230. He also acknowledged that he has no patents regarding the growing of any medicinal plants.
Id.
at 238.

Discussion

Pursuant to 21 U.S.C. 823(a), “[t]he Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest and with the United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971.” 21 U.S.C. 823(a). “In determining the public interest,” § 823(a) directs the Attorney General to consider the following factors:

(1) Maintenance of effective controls against diversion of particular controlled substances and any controlled substances in schedule I or II compounded therefrom into other than legitimate medical, scientific, research, or industrial channels, by limiting the importation and bulk manufacture of such controlled substances to a number of establishments which can produce an adequate and uninterrupted supply of these substances under adequately competitive conditions for legitimate medical, scientific, research, and industrial purposes;

(2) Compliance with applicable State and local law;

(3) Promotion of technical advances in the art of manufacturing these substances and the development of new substances;

(4) Prior conviction record of applicant under Federal and State laws relating to the manufacture, distribution, or dispensing of such substances;

(5) Past experience in the manufacture of controlled substances, and the existence in the establishment of effective controls against diversion; and

(6) Such other factors as may be relevant to and consistent with public health and safety.

Id.
This Agency's regulations further provide that “[a]t any hearing on an application to manufacture any controlled substance listed in Schedule I or II, the applicant shall have the burden of proving that the requirements for such registration pursuant to [§ 823(a)] are satisfied.” 21 CFR 1301.44(a).

As § 823(a) makes plain, even if an applicant satisfies its burden of proof with respect to the public interest inquiry, it cannot be granted a registration unless its proposed activities are consistent with the United States' obligations under international treaties. The United States is a party to

the Single Convention. Accordingly, whether Respondent's proposed activities are consistent with this Nation's obligations under the Convention is a threshold question.

A. Whether Respondent's Proposed Registration Is Consistent With the Single Convention

The Single Convention imposes a comprehensive series of measures to control narcotic drugs and other substances including marijuana (which is referred to in the Single Convention as “cannabis”).
49

Under the Convention, cannabis is both a Schedule I and Schedule IV
50

drug and is subject to the control measures applicable to each schedule. Single Convention, art. 2, para. 5;
see also
Secretary-General of the United Nations,
Commentary on the Single Convention on Narcotic Drugs, 1961,
65 (1973) (hereinafter, Commentary). Moreover, under article 28, “[i]f a Party permits the cultivation of the cannabis plant for the production of cannabis or cannabis resin, it shall apply thereto the system of controls as provided in article 23 respecting the opium poppy.” Single Convention, art. 28, Para. 1. As the Commentary further explains:

49
Under the Single Convention, “ ‘cannabis plant' means any plant of the genus Cannabis.” Article 1(c). The Single Convention defines “cannabis” to include “the flowering or fruiting tops of the cannabis plant (excluding the seeds and leaves when not accompanied by the tops) from which the resin has not been extracted, by whatever name they may be designated.” Article 1(b). This definition of “cannabis” under the Single Convention is less inclusive than the CSA definition of “marihuana.”
See
21 U.S.C. 802(16). However, this distinction in inconsequential for purposes of the matters at issue in this proceeding.

50
The Single Convention's use of the term “Schedule IV” is not to be confused with the CSA's use of the same term. Under the Convention, the terms “Schedule I, Schedule II, Schedule III and Schedule IV mean the correspondingly numbered list of drugs or preparations annexed to this Convention.” Single Convention, art. 1, para. 1(u). As the Convention further explains, “[t]he drugs in Schedule IV shall also be included in Schedule I and subject to all measures of control applicable to drugs in the latter Schedule” as well as the additional measures contained in article 2, paragraph 5.
Id.
art. 2, para. 5.

Under Article 2, paragraph 5, the Convention requires that [a] Party shall adopt any special measures of control which in its opinion are necessary having regard to the particularly dangerous properties of a drug so included.
Id.
art. 2, para. 5(a). The Convention further directs that:

A Party shall, if in its opinion the prevailing conditions in its country render it the most appropriate means of protecting the public health and welfare, prohibit the production, manufacture, export and import of, trade in, possession or use of any such drug except for amounts which may be necessary for medical and scientific research only, including clinical trials therewith to be conducted under or subject to the direct supervision and control of the Party.

Id.
art. 2, para. 5(b).

The system of control over all stages of the drug economy which the Single Convention provides has two basic features: limitation of narcotic supplies of each country * * * to the quantities that it needs for medical and scientific purposes, and authorization of each form of participation in the drug economy, that is, licensing of producers, manufacturers and traders. * * * In the case of the production of opium, coca leaves, cannabis and cannabis resin, this regime is supplemented by the requirement of maintaining government monopolies for the wholesale and international trade in these drugs in countries which produce them. * * *

Commentary at 263.

Among

these controls is the requirement that “[t]he Agency shall * * * have the exclusive right of importing, exporting, wholesale trading and maintaining stocks other than those held by manufacturers of opium alkaloids, medicinal opium or opium preparations.” Single Convention art. 23, para. 2(e). The Convention further provides, however, that the “Parties need not extend this exclusive right to medicinal opium and opium preparations.”
51

Id.

51
Article 23 of the Convention further provides that “[a] Party that permits the cultivation of the opium poppy for the production of opium shall establish, if it has not already done so, and maintain, one or more government agencies * * * to carry out the functions required under this article.” Single Convention art. 23, para. 1. Moreover, “[a]ll cultivators of the opium poppy shall be required to deliver their total crops of opium to the Agency. The Agency shall purchase and take physical possession of such crops as soon as possible, but not later than four months after the end of the harvest.”
Id.
para. 2(d).

The Commentary to article 28 thus explains that “[a] Party permitting the cultivation of the cannabis plant for cannabis and cannabis resin must, pursuant to article 23, paragraph [2(e)(2)] in connexion with article 28, paragraph 1, grant its national cannabis agency
the exclusive right of wholesale * * * trade in these drugs.
” Commentary at 314 (emphasis added). The Commentary further explains that the Government “need not extend this exclusive right to extracts and tinctures of cannabis.”
Id.

Respondent raises several arguments as to why his registration would be consistent with the Single Convention. First, he argues that “the Convention clearly contemplates that more than one cultivator or bulk manufacturer may be licensed by the member nation's licensing agency.” Resp. Prop. Findings at 66. Second, he argues that because his “crop would be medical marijuana, grown and processed to be adapted for medicinal use, it is not subject to the agency's ‘exclusive right’ for ‘maintaining stocks.’ ”
Id.
at 67.

Relatedly, Respondent argues that because DEA has granted Dr. ElSohly a registration to “grow marijuana for private purposes” and does not require him to “turn[] over those stocks to any government agency,” granting his application will likewise conform with the Single Convention. Respondent further contends that Dr. ElSohly has been able to grow marijuana outside of the NIDA contract and that “DEA would not have issued those licenses had they violated the Single Convention.”
Id.
at 68. Respondent also argues that the United Kingdom, which is also Party to the Convention, has allowed marijuana to be grown by a private entity (GW Pharmaceuticals) without its government taking physical possession.
Id.
Likewise, in his Response to the Government's exceptions to the ALJ's recommended decision, Respondent argues that the ALJ “correctly held that Article 23 [para.] 2(d) does not require the government to take physical possession of [his] crop.” Respondent's Resp. at 9.

In concluding that the “Single Convention does not preclude registering Respondent,” the ALJ offered three reasons. First, based on the United Kingdom's regulatory scheme, she reasoned that “it appears * * * that the parties to the Single Convention are free to construe the term ‘physical possession’ as they see fit.” ALJ 82. As for the remaining two reasons, the ALJ explained that “[i]t also appears, although it is not entirely clear, that the marijuana grown by the National Center or by any other registrant for utilization in research would qualify as either ‘medicinal’ within the meaning of article 1, paragraph (1)(o), or a ‘special stocks’ within the meaning of article 1, paragraph (1)(x), and that therefore the government monopoly on importing, exporting, wholesale trading, and maintain stocks would not apply.”
Id.

Neither the ALJ's rationales nor Respondent's arguments are persuasive. As for the argument that the Single Convention does not require that the Government take physical possession, the argument provides no comfort to Respondent for two reasons. First, the argument ignores that taking possession and engaging in wholesale distribution are two separate activities under the Convention. Notably, in his briefs, Respondent does not even acknowledge the distinction.
See
Resp. Proposed Findings and Conclusion of Law at 64-70; Respondent's Resp. at 9-12.

Second, as Respondent's evidence makes clear, his purpose for seeking a registration is not simply to grow marijuana, but to distribute it outside of the HHS system. Mr. Doblin's testimony

that “what we're trying to do is get the [PHS] and NIDA out of the picture,” Tr. 666, makes this plain.
See also
Tr. 225 (testimony of Respondent; “I may very well be approached by other people with approved studies who need a source also.”). Thus, Respondent's contention that the Single Convention does not prohibit multiple cultivators is beside the point, since his proposed purpose for gaining authorization to grow marijuana (so that MAPS—rather than HHS/NIDA—can control distribution of the marijuana) would defy one of the central control provisions of the Single Convention with respect to cannabis cultivation. As the Commentary to the Single Convention states:

Countries * * * which produce * * * cannabis * * * , [i]n so far as they permit private farmers to cultivate the plants * * *, cannot establish with sufficient exactitude the quantities harvested by individual producers. If they allowed the sale of the crops to private traders, they would not be in a position to ascertain with reasonable exactitude the amounts which enter their controlled trade. The effectiveness of their control régime would thus be considerably weakened. In fact, experience has shown that permitting licensed private traders to purchase the crops results in diversion of large quantities of drugs into illicit channels. * * * [T]he acquisition of the crops and the wholesale and international trade in these agricultural products cannot be entrusted to private traders, but must be undertaken by governmental authorities in the producing countries. Article 23 * * * and article 28 * * * therefore require a government monopoly of the wholesale and international trade in the agricultural product in question in the country which authorizes its production.

Commentary at 278. Indeed, the central theme of Respondent's argument—starting with the opening sentence of his Proposed Findings and Conclusion of Law and repeated throughout the document—is that the very Government monopoly over the wholesale distribution of marijuana that the Single Convention demands is the primary evil that Respondent seeks to defeat through obtaining a DEA registration. Thus, from the outset of the analysis, Respondent's proposed registration cannot be reconciled with United States obligations under the treaty.

Respondent offers no argument that his proposed distributions would not constitute wholesale trading under the Convention.
See, e.g.
, GX 3, at 3 (“customers would include both MAPS-sponsored research and research sponsored by other organizations.”). Respondent's proposed activity in distributing to researchers does not constitute retail trading because his customers are not the ultimate users of the marijuana, but rather researchers, who would then dispense the drugs to ultimate users.
See
Commentary at 329 (A manufacturer's “license does not in any event * * * include the retail trade in drugs.”).
52

52
Under the CSA and DEA regulations, wholesale distribution and dispensing (retail distribution) are independent activities and require separate registrations.
See
21 U.S.C. 802(11) (definition of “distribute” excludes dispensing);
compare
21 U.S.C. 823(b)
with
823(f) (separate registration required for distributor versus dispenser);
see also
21 CFR 1301.13(e) (listing categories of registration and authorized activities). Only a practitioner (and not a manufacturer or distributor) can dispense a controlled substance to a patient.
See id.
at 1301.13(e)(1).

Moreover, the Single Convention is a drug-control regime. The precise economic arrangements between Respondent, MAPS, and any other potential customers, are therefore irrelevant in determining whether his proposed activity would constitute wholesale trading.

In construing the meaning of “United States obligations under [the Single Convention]” in the context of 21 U.S.C. 823(a), any reliance by the ALJ or Respondent on the United Kingdom's practice is misplaced.
53

For one, as set forth in § 823(a), Congress assigned to the Attorney General sole authority to determine whether a proposed registration under this provision is consistent with United States obligations under the Single Convention. Nowhere in the CSA does Congress call upon the Attorney General to rely on—or even consider—how other nations interpret the Single Convention as a basis for the Attorney General's determination of what are the United States obligations under the treaty.
54

Second, the Single Convention contains provisions that call upon each nation that is a party to the treaty to determine, in its own opinion, whether and how to tailor its control measures commensurate with the circumstances particularized to that country. For example, article 2, paragraph 5, of the Single Convention states the following with respect to drugs included in Schedule IV (including cannabis):

53
There was a dispute between the parties as to the admissibility of the document Respondent submitted (attached to RX 26) purporting to set forth the United Kingdom's explanation of how it carried out its obligation under the Single Convention to establish a national cannabis agency. Tr. 1812. After having the parties brief the issue, the ALJ noted, in a “Memorandum to Counsel and Ruling,” that one of the Government's objections was that Respondent did “not explain how exhibit 26 was issued or under what authority.” The ALJ concluded that “although the circumstances under which exhibit 26 came to be promulgated are not clear, it appears that the document is in effect in the United Kingdom.”
Id.
The ALJ did not explain her basis for this conclusion.
See id.
It is unnecessary to determine whether this ruling by the ALJ was proper because, even assuming,
arguendo,
that the document accurately represented the official position of the United Kingdom and was issued by the appropriate representative of the British Government, for the reasons explained above, reliance on this document for determining how to interpret the Single Convention for purposes of 21 U.S.C. 823(a) is inappropriate.

54
For this reason, it is unnecessary to expressly reject the interpretation contained in the document submitted by Respondent (attached to RX 26) titled “United Kingdom National Cannabis Agency: Protocol.”

(a) A Party shall adopt any special measures of control which in its opinion are necessary having regard to the particularly dangerous properties of a drug so included; and

(b) A Party shall, if in its opinion the prevailing conditions in its country render it the most appropriate means of protecting the public health and welfare, prohibit the production, manufacture, export and import of, trade in, possession or use of any such drug except for amounts which may be necessary for medical and scientific research only, including clinical trials therewith to be conducted under or subject to the direct supervision and control of the Party.

Thus, what the United Kingdom might, in its opinion, deem to be appropriate control measures to meet its obligations under the Single Convention given the circumstances involving cannabis in Britain might be distinct from what the United States finds, in its opinion, to be the appropriate control measures to fit the circumstances involving cannabis in the United States.
55

55
In any event, there is no evidence that the British Government has allowed GW to engage in the type of activity for which Respondent seeks to become registered—the wholesale distribution of plant-form marijuana. Rather, as DEA has done with respect to the National Center and its project to supply THC extract to Mallinckrodt (GX 78), the British Government has granted GW a license to grow marijuana for the limited purpose of producing extract for a pharmaceutical product. Rx 26, Ex. A at 2.

If the United States were to look to any outside entity for guidance on compliance with the Single Convention, that entity would be the International Narcotics Control Board (INCB), which is the United Nations organ created by the Single Convention to implement, and monitor compliance with, the Convention.
See
Single Convention, articles 5, 9-15, 19-20. In its 2005 Annual Report, the INCB reiterated: “Articles 23 and 28 of the [Single] Convention provide for a national cannabis agency to be established in countries where the cannabis plant is cultivated licitly for the production of cannabis, even if the cannabis produced is used for research purposes only.”
56

Similarly, the INCB issued a statement in 2008 stating, with respect to the standards under the Single Convention

relating to the control of cannabis, that “[s]uch standards require, inter alia, the control of cultivation and production of cannabis by a national cannabis agency.”
57

As explained above, it is this control of the cultivation and production of cannabis by a national agency of the United States to which Respondent is fundamentally opposed, thereby demonstrating the inconsistency between his application and the Single Convention.

56
The above-quoted statement appears on page 16, in paragraph 81, of the 2005 INCB Annual Report, which is available at
http://www.incb.org/pdf/e/ar/2005/incb_report_2005_2.pdf
. I take official notice of the report.

57
This statement was made in an INCB press release issued on February 8, 2008, which is available at
http://www.unis.unisvienna.org/unis/pressrles/2008/usinar1023.html
, and of which I take official notice.

The ALJ further reasoned that “although it is not entirely clear,” the marijuana Respondent seeks to grow would be exempt from the Government's exclusive right to engage in wholesale trading because it would qualify as either “medicinal” or “special stocks.” ALJ at 82. As explained below, the ALJ erred on both counts.

In his response to the Government's exceptions, Respondent contends that the “[t]he Single Convention defines ‘medicinal’ marijua

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3AE9-521. Public record. Not legal advice.