Marijuana Dispensaries and the Federal Government: Recommendations to the Obama Administration 2009: Part 2
Andrea G. Barthwell, M.D.

Michael C. Barnes, Esq.
DCBA Law & Policy

The Scientific Process

Crude Herbal Cannabis and Unstandardized Cannabis Preparations Do Not Meet the Standards of Modern Medicine.
The Institute of Medicine (IOM) has recognized that crude herbal cannabis has little future as a true medication:

Although marijuana smoked delivers THC and other cannanbinoids 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.(50)

The IOM stressed that “the purpose of clinical trials of smoked marijuana would not be to develop marijuana as a licensed drug but rather to serve as a first step toward the development of nonsmoked rapid-onset cannabinoid delivery systems.”(51)

The FDA agrees that crude herbal cannabis is not a medication.(52) The California Medical Association recently announced its intention to “re-examine the need for continued research on smoked herbal cannabis in light of recent research on its benefits and harm and the long-term prospect of smoked herbal cannabis as a medicine.”(53) The DEA also acknowledges the need for standardized product:

[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.(54)

Only Recently Has Technology Made Possible the Development of Modern Cannabis-derived and Cannabinoid Medications.
There are good reasons why the development of cannabis-derived medications has lagged far behind that of synthetic and naturally-derived opioids and other modern medications. Given that the active ingredients (morphine, codeine) of opium are water soluble, it was relatively simple in the 19th and early 20th centuries to isolate them and develop standardized and purified medications with the technologies that existed at that time.(55)

The story of cannabis is quite different. Cannabinoids (especially THC) are lipophilic (i.e., not water soluble) and unstable, making it difficult for early scientists to identify and isolate the active ingredients. Consequently, potentially therapeutic applications were limited to oral preparation of cannabis (tinctures and extracts),(56) which could not be adequately standardized. Patient response was variable and unpredictable. As more modern medicines became available, these unreliable extracts and tinctures fell out of favor with the medical profession.(57)

The modern era of cannabinoid research was in its infancy in 1964, when the primary psychoactive ingredient of cannabis, THC, was isolated and then synthesized.(58) Beginning in 1989, a robust body of cannabinoid research began to develop, following scientists’ discovery of the human cannabinoid receptor system.(59) This delay in the development of modern cannabinoid and cannabis-derived medications has, therefore, been caused more by past technological limitations, than by governmental obstructionism. That development gap is now slowly closing, and there is no justification for affording a non-scientific acceleration, i.e., a “free pass,” to herbal cannabis:

This evolution has followed the same principles as the evolution of drug therapy in general. The direction has been away from crude substances of variable composition, stability, and potency, toward the development of progressively more specific or selectively active pure compounds that permit more precise dosage and reduced risk of unwanted side effects.(60)

This is not to say that complex botanically-derived preparations cannot pass FDA muster. There is strong evidence that some properly tested and standardized plant preparations, including those derived from cannabis, may offer different -- and better -- pharmacological effects than a pure, synthesized cannabinoid alone.(61)

The FDA has recognized that there is burgeoning scientific and public interest in botanically-based products, and that modern technology makes it possible to develop medications of botanical origin. In order to guide the development of such products, the agency has set forth the criteria that must be met to achieve FDA approval.(62) While allowing some flexibility at the early stages of medication development, the guidance specifically states that, by the time of Phase 3 clinical studies,(63) the requirements for a botanical drug product are virtually the same as to those that apply to a new chemical entity (NCE). Botanical Raw Material (BRM), such as herbal cannabis, has not been formulated, incorporated into a specific dosage form, and tested through this demanding NCE process. The FDA guidelines make it quite clear that, even if crude herbal cannabis were moved to Schedule II, it could not thereby be marketed and distributed directly to patients.

The Administration Should Respect and Support the Proper Workings of the Scientific Process.
As a result of modern technologies, and as demonstrated by the receptor research mentioned above, there is significant interest within the scientific and medical communities in cannabinoid research. Scientists are moving as expeditiously as possible to bring new cannabinoid products to market. Time is required, however, for such research to be conducted in accordance with modern medical standards. In keeping with its commitment to science, this Administration should do nothing to discourage these efforts. As President Obama has stated:

Medical miracles do not happen simply by accident. They result from painstaking and costly research, from years of lonely trial and error, much of which never bears fruit, and from a government willing to support that work.(64)

The United States is, indeed, supporting such work in this area. For example, the FDA has allowed a cannabis-derived product to enter into advanced clinical trials in the U.S. For the past ten years, research has been underway in the United Kingdom by GW Pharmaceuticals to develop a range of prescription medications derived from the components of the cannabis plant.(65) GW cultivates particular strains of cannabis that have been bred to express specific ratios of cannabinoids. In order to maintain the consistency of the plants’ chemical composition, they are grown by clones (cuttings) under highly-standardized and computer-controlled conditions in secure glasshouses. GW extracts the pharmacologically-active components of the plant, removes waxes and other unwanted constituents, and formulates the resulting botanical drug substance into a final dosage form of specified composition, which is characterized by various standard chromatographic techniques.

The company’s lead product, Sativex®, is an oromucosal (inside of the mouth) spray composed primarily of THC and CBD. It is believed that this combination has distinct and important pharmacological activity. The product has already been approved in Canada for neuropathic pain in multiple sclerosis and for cancer pain. The DEA has licensed the importer(66) and the research sites.

A number of other companies, including Alexa Pharmaceuticals, Inc. (THC aerosol product); Aphios (naturally-derived THC product); and Insys Therapeutics, Inc., are also developing cannabinoid products in the U.S.(67) All of these research programs are moving through the conventional domestic regulatory process.(68) None is attempting to distribute crude herbal cannabis, or non-standardized botanical preparations, to pharmacies and patients.(69) These research programs indicate that cannabis-derived medications can, and therefore should, be developed within the parameters of modern regulatory oversight. Allowing a proliferation of cannabis dispensaries would undermine these efforts to bring properly tested medications to market, a result at odds with this Administration’s position that its policies should be based on sound science.(70)

Developing properly standardized and tested cannabis-derived or cannabinoid medications is not an easy matter; it requires patience, perseverance, and a commitment of substantial resources. But numerous medical tragedies(71) have proven that shortcuts to the FDA process do a disservice to patient safety and well-being. The FDA drug approval process is not perfect, as demonstrated by recent news about previously-unknown dangers of marketed medications, such as Vioxx®.(72) The lesson of these experiences, however, is not that we should do less testing, or lower our current standards, for prescription medicines. Indeed, those incidents have led to demands for greater oversight by the FDA and, recently, for the establishment of an independent institute to examine the comparative safety and effectiveness of medications.(73)

The FDA Has Limited Power to Protect Patients Who Seek Medical Treatment and Advice From Cannabis Dispensaries.
The FDA has limited jurisdiction to address the dangers posed by cannabis dispensaries. The provisions of the FDCA govern only products that have been introduced into interstate commerce. Therefore, it can be argued that the activities of intra-state cannabis dispensary operations are beyond the reach of the FDA. Ironically, the FDA has greater power over dietary supplements (which have generally passed through interstate commerce) and over health food stores than it does over cannabis dispensaries and their operators.(74) Indeed, the manufacturers of herbs and other dietary supplements (and the retail establishments that sell them) are prohibited by federal law from making claims regarding the product’s medical usefulness or specific health effects.(75) Cannabis dispensaries, however, do give out advice, and provide books and pamphlets, containing such medical claims.(76)

The DEA, therefore, plays a critical part in protecting patients from dangerous, ineffective, and federally unapproved cannabis products. The CSA, and therefore the DEA’s authority, extends to products containing controlled substances and activities that may affect interstate commerce, even if the specific products have been manufactured and distributed solely within the state.(77) If this Administration ties the DEA’s hands with regard to dispensaries, patients will lose altogether any avenue of federal protection.

States Laws and Regulatory Bodies Should Enhance, Rather Than Undermine, the Protections Provided by the FDA System.
In cases other than medical marijuana, the FDA and DEA are able to rely to a large extent on state regulatory and law enforcement systems to support and augment the federal structures. States have generally accepted this responsibility, enacting their own food and drug laws to fill the gap in the FDA’s jurisdiction. These state laws are, for the most part, modeled after the federal FDCA. In California, for example, the Sherman Food, Drug, and Cosmetic Law (“Sherman Law”) establishes rigorous scientific standards that must be met before a new drug may be marketed for medical use. The Sherman Law states that a new drug generally may not be sold, delivered, or given away unless a new drug application has been filed with, and approved by, the state or federal government.(78)

State regulatory boards and agencies similarly enhance the effectiveness of the FDA and DEA. State boards of medicine, nursing, pharmacy, etc., supervise the education, training, and practices of all health care providers who examine or advise patients, or dispense or distribute medications. Health care providers who do not adhere to accepted standards of medical practice may incur sanctions from these boards, as well as risk potential civil liability for inappropriate prescribing or other conduct falling below the standard of care.(79) Health care facilities are monitored and licensed by state departments of health services. State tort systems allow patients who have suffered injury from a medication to seek damages from the manufacturer, even if that medication has been FDA-approved.(80) These state mechanisms, when they operate effectively, provide patients with additional or greater avenues of redress and protection and, thereby, complement federal food and drug provisions.

By contrast, when states utilize their food and drug laws (or enact other state legislation) for the purpose of circumventing the FDCA, patient health and safety is jeopardized. In many ways, the current cannabis controversy parallels the Laetrile controversy of the 1970s. At that time, Laetrile (amygdalin) was vigorously promoted as a cancer treatment and preventative. Despite efforts by its supporters to characterize it as a dietary supplement (“Vitamin B17”), the FDA determined that Laetrile was a new drug (since it was intended for medical use) and was subject to premarketing approval.(81) Since it had not been proven safe and effective for medical use, the FDCA precluded Laetrile’s shipment in interstate commerce. Desperate cancer patients, spurred on by anecdotal reports of efficacy, contended that they had a right to use Laetrile, despite evidence of cyanide toxicity. Laetrile advocates claimed that the FDA, the American Medical Association, the American Cancer Society, the pharmaceutical companies, and others were conspiring against Laetrile.(82) This political pressure, rather than scientific evidence, caused twenty-seven state legislatures to pass laws allowing the sale and use of Laetrile within their borders. These state laws had little effect, since it was not feasible to manufacture Laetrile within each state. “Proponents hoped, however, that if enough states legalized its use within the states, Congress would change the federal law as well.”(83) Ultimately, the National Cancer Institute conducted clinical testing and determined that Laetrile was not effective as a cancer treatment.(84) The lesson of Laetrile is that state legislation should only be used to enhance, rather than undermine, the protections of the federal regulatory system.

The same is true with regard to controlled substances. Many states have adopted the Uniform Controlled Substances Act,(85) the provisions of which parallel those of the federal CSA. States can serve as an early warning system, and have the flexibility to respond more quickly to abuses of controlled substances -- or of uncontrolled substances with abuse potential -- within their borders.(86) For example, as an added layer of protection, states may require that individuals who conduct research into controlled substances must be independently inspected, licensed, and/or approved by state agencies, in addition to obtaining DEA registrations.(87) States may enact prescription monitoring programs to track physicians who prescribe controlled substances, in order to identify and stop inappropriate prescribing practices by physicians, as well as “doctor shopping” by patients (obtaining prescriptions from multiple doctors simultaneously).(88) States also have greater flexibility in their scheduling actions. If a state believes that a new substance has abuse potential and poses a threat to patient safety or public health, the state need not wait on the DEA; it may schedule that substance more restrictively, or prohibit its sale and use altogether.

Cannabis Dispensaries Are Not Subject to State Laws and Regulations Applicable to Entities Operating in the Health Care Area.
Cannabis dispensaries starkly conflict with this robust state system of patient-oriented controls. “Pot docs,” for cash payments of several hundred dollars, provide recommendations to patients (including minors), with whom they have virtually no physician-patient relationship, to enable them to use cannabis for a wide variety of medical conditions.(89) Patients purchase cannabis from dispensaries with which they have only a retailer-consumer relationship. Dispensary personnel need not be licensed as health care providers, nor are they required to follow proper sterile techniques to protect against on-site bacterial(90) or other contamination of the herbal material, although it is intended for consumption directly by patients.(91) Despite their lack of training and accreditation, such personnel freely offer medical information and advice to patients(92) about the panoply of cannabis products, including extracts, capsules, tablets, and various types of edibles. Some of these products can reach THC concentrations as high as 80%, which could produce significant side effects, especially in seriously ill patients or those who have not used cannabis before.(93)

At best, cannabis dispensaries are regulated at the local level.(94) Where they are permitted by local legislation (as in San Francisco),(95) such dispensaries are not regulated as if they were health care facilities (e.g., clinics or pharmacies) answerable to the state department of health services. Nor are the employees who provide direct patient service (e.g., distributing medical marijuana or medical advice) subject to the scope of practice restrictions and requirements supervised by the state boards of pharmacy, nursing, and medicine. Rather, dispensaries are regulated as if they were retail establishments, subject only to the Building, Planning, Housing, Police, Fire, and Health codes of the local jurisdiction.(96)

Cannabis and Cannabis-Derived Products Should be Governed by the Quality Control and Other Testing Procedures Applicable to All Modern Medications.
Gradually, even some cannabis dispensaries have begun to voice concern that these unregulated distribution practices may be placing patients in danger. One operator has acknowledged that, if cannabis “is going to become an accepted mainstream medicine,” there must be quality assurance and dosage information:

[A] dog walks in the grow room, and wags its tail—anything can be coming off that dog’s tail. It’s gross. Fertilizers with E. coli. Compost ... that they don’t make right, anaerobic tea that has elevated levels of E. coli and salmonella. It has to come. There’s no way that this is sustainable. All it takes is one story of immune-compromised people dying from Aspergillus infection.(97)

This operator has affiliated with an informal laboratory, and envisions a testing program using such instruments as a gas chromatograph and mass spectrometer.(98) He also notes, however, that “It’s expensive to test every single thing that comes through the door—that’s the price you pay with a decentralized supply system… five pounds coming from here and two from there.”(99) It is far from certain whether other dispensaries would voluntarily join such an effort.

These rudimentary laboratory-testing efforts merely confirm the importance of adhering to the existing body of technological tools and methodologies mandated by state and federal regulatory agencies. There is no need to “recreate the wheel” for cannabis or cannabis-derived preparations. Drug manufacturers are already required to institute extensive testing procedures to ensure that their products are quality-controlled during manufacture, and that their formulations and dosage forms are standardized and reproducible. Testing procedures must be validated, instruments must be calibrated, equipment operators must be appropriately educated and trained, careful records must be kept, and practices must be sterile. Finished medical products must be analyzed for batch-to-batch consistency, and any degradants and minor contaminants must be identified and strictly limited.

Should a system of cannabis-testing laboratories ultimately develop at all, it is hard to imagine that it would be allowed to operate at a different or inferior level to the current U.S. medication-development system. If cannabis dispensaries are allowed to proliferate across the country, our current regulatory system, to which the American Medical Association and all other major U.S. medical associations give their unwavering support, may be seriously undermined.

If there were only a single state with a few dispensaries, the risk might not be as significant. At present, however, 13 states have laws decriminalizing the use of cannabis for medical purposes, and bills are pending in many more states.(100) If such cultivation and distribution activities are deemed to be beyond the reach of the DEA, dispensaries are likely to emerge all over the country.(101)

Good Science Should Also Guide Decisions Implementing Our Obligations Under International Drug Control Treaties.
President Obama has announced his intention to trust science and research when designing our international, as well as domestic, policies. Sound science should inform and guide this Administration as it implements our international responsibilities in the field of drug control policy. The U.S. -- and thereby the Department of Justice -- has an obligation under our international drug control treaties to control strictly the manufacture and distribution of controlled substances, including the cultivation and distribution of cannabis, within our borders.

In particular, if the U.S. permits the cultivation of cannabis plants for medical use, it must apply the same provisions as are imposed for the cultivation of the opium poppy for medical use. This rigorous system of controls must be maintained by a single government agency. States, therefore, cannot have sole jurisdiction over the proliferation of cannabis dispensaries.

The United States is a signatory to the Single Convention on Narcotic Drugs 1961 (“Single Convention”).(102) This treaty was intended to ensure that the production and use of narcotic substances are limited exclusively to bona fide medical and scientific purposes.(103) Accordingly, the Single Convention requires a party to impose strict controls, not merely on international trade, but also on domestic manufacture, distribution, import, export, and possession of botanically-derived controlled substances (such as coca, opium, and cannabis).

The phrase “medical and scientific purposes” has a clear meaning. The treaty was promulgated at a time when governments around the world were developing regulatory procedures to ensure the quality and safety of medical products.(104) Crude narcotic plant material was not considered suitable for direct medical use. For example, under the treaty, opium smoking was not an accepted method for delivering the therapeutically useful components contained within the herbal material.(105)

The Single Convention recognized that different countries may have different regulatory systems.(106) However, the treaty expected that each party would in good faith adhere to modern scientific standards: that is, employ conventional regulatory standards when determining whether, when, and which, narcotic substances and products could be made available for medical use. Nowhere in the treaty is there any suggestion that a Party may allow a diluted or informal medical system solely for a specific controlled substance such as cannabis.

In response to the activities of medical cannabis proponents, the International Narcotics Control Board (INCB)(107) stressed that a party may not allow cannabis to be cultivated, manufactured, and used for medical purposes unless such products have satisfied the rigorous regulatory standards that apply to other medical products. Such use must be supported by objective scientific data from properly-conducted research studies, and must otherwise accord with principles of modern medicine.(108)

The Single Convention places particularly severe restrictions on the cultivation of cannabis, opium, and coca bush. Article 23 requires that, if a party permits(109) cultivation of opium poppies within its borders, the Party must establish and maintain a national Agency to carry out the Party’s obligations. Articles 26 and 28 apply those requirements to the cultivation of the coca bush and the cannabis plant, respectively. Article 23 requires that only nationally-licensed cultivators, whose license specifically identifies the precise extent and location of the land that they are authorized to cultivate, may grow such narcotic plants.(110) They must deliver their total crops to the Agency, and only the national Agency may deal with such crops. The Agency must have the exclusive right of importing, exporting, wholesale trading, and maintaining stocks.(111)

The National Institute on Drug Abuse (NIDA) serves as the U.S. national Agency under the Single Convention.(112) Under the auspices of NIDA, the U.S. maintains a domestic cultivation facility, in which research-grade cannabis is cultivated by the National Center for Natural Products Research at the University of Mississippi under contract with NIDA.(113) This cannabis is supplied to investigators who have research protocols that have been approved by the FDA and by an expert committee of the Public Health Service, and who have obtained research registrations from the DEA.(114) As of April 2004, the University of Mississippi, with the approval of NIDA and the PHS committee,(115) had provided cannabis to more than 17 clinical and preclinical studies funded by the Center of Medicinal Cannabis Research (CMCR) at the University of California San Diego.(116)

If, in the future, cannabis-derived medications were to be developed and approved for marketing, it would not be necessary for the cannabis cultivation (production of starting materials) to take place in the United States. The herbal material, or the Botanical Drug Substance (extracts) could be imported into the U.S. for further formulation. For over 85 years, it has been the policy of the U.S. not to cultivate or produce narcotic raw material (NRM), such as opium, poppy straw, and concentrate of poppy straw (CPS).(117) By long-standing international policy, the U.S. is a country that imports and consumes, rather than one that produces and supplies, NRM.(118) The U.S. relies on a specific list of countries authorized to import NRM into the U.S. in order to meet the legitimate medical needs of the U.S.(119) This list is deliberately kept very short, in order to prevent a proliferation of NRM-producing countries.

112. NIDA, “Provision of Marijuana and Other Compounds for Scientific Research—Recommendations of the National Institute on Drug Abuse National Advisory Council,” http://www.nida.nih.gov/about/organization/nacda/marijuanastatement.html.

113. See, DEA, “Lyle E. Craker; Denial of Application,” 74 Fed. Reg. 2101, 2104 (Jan. 14, 2009) (hereinafter Craker Application). Professor Lyle Craker, a plant scientist at the University of Massachusetts, sought to be registered as a bulk manufacturer to cultivate herbal cannabis, which he intended to provide to researchers with FDA-approved INDs and DEA research registrations. The DEA Deputy Administrator denied his application on a number of bases: 1) there was no evidence that the quality or supply of NIDA cannabis was inadequate nor its cost excessive; 2) Prof. Craker and his sponsor, the Multidisciplinary Association for Psychedelic Studies (MAPS), were seeking “to dismantle the existing Government control over the distribution of cannabis produced by growers” and “avoid the governmental monopoly over the wholesale distribution of marijuana that is mandated by the Single Convention,” by distributing it outside of the HHS system, id. at pp. 2114, 2117, 2122; 3) Prof. Craker, unlike Dr. Mahmoud ElSohly, the Principal Investigator of the National Center project, had no experience in the manufacture of controlled substances and could not demonstrate that he was capable of producing cannabis with any degree of quality control, id. at p. 2121 fn. 74; 4) there was no evidence that MAPS had the knowledge or expertise to use such cannabis to develop an FDA-approved product, id. at p. 2106, 2123. This case leaves open the question of whether the DEA might agree to register an additional bulk manufacturer who possessed the appropriate expertise and who was willing to abide by the provisions of the Single Convention. See fn. 115 below. The DEA noted that the U.K. has granted GW Pharmaceuticals a license to grow cannabis “for the limited purpose of producing extract for a pharmaceutical product.” Id. at p. 2115 fn. 55.

114. The National Center holds an additional registration to manufacture cannabis and THC under the terms of a Memorandum of Agreement with the DEA in 1999. The purpose of this registration is 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 2104, fn 13.

115. In 1999, the National Institutes of Health announced new procedures for making research-grade cannabis available to researchers, including those whose research is privately-funded. http://www.nih.gov/news/medmarijuana/hhsfact.htm

116. Craker Application at p. 2105.

117. See DEA, “Authorized Sources of Narcotic Raw Materials,” 73 Fed. Reg. 6843 (Feb. 6, 2008).

118. 44 Fed. Reg. 33696 (June 12, 1979).

119. Those countries are India , Turkey , France , Poland , Hungary , Australia , and Spain . See DEA, “Authorized Sources of Narcotic Raw Materials,” 73 Fed. Reg. 6843 (Feb. 6, 2008).

120. The treaty obligates the U.S. and other parties to license and control all persons and entities engaged in the manufacture of narcotic substances and products, as well as to control under license the premises where such manufacture takes place. In addition, those manufacturers must obtain “periodical permits” indicating the kinds and amounts of drugs they are authorized to manufacture (Art. 29). The Party must control all persons and entities distributing such substances and license the premises in which such distribution takes place. Art. 30. Finally, the Parties must require all licensees to have adequate qualifications (Art. 34(a)). They must require all manufacturers, traders, scientists, scientific institutions and hospitals to keep records for two years showing 1) the quantities of each drug manufactured and 2) each individual acquisition and disposal of drugs (Art. 34(b)). The Parties are obligated to impose specific requirements and restrictions on the labeling and import/export of a medication. (Art. 30-31). The provisions of the CSA, in conjunction with those of the Food, Drug & Cosmetic Act, satisfy these obligations.

121. In addition to these controls, the Single Convention, in an effort to prevent legitimate medical products from being diverted to illicit use, imposes strict requirements on Parties to provide annual estimates regarding quantities of drugs utilized or held for specific purposes, Art. 19, as well as statistical returns concerning, among other things, production, manufacture, consumption, imports/exports, seizures/disposals, and year-end stocks. Art. 20. These requirements apply even to substances used in research. INCB, Narcotic Drugs 2002 at p. 97 (2003) (recognizing appropriateness of UK reporting of amounts of cannabis extracts used for medical research). Even if an individual practitioner or scientist wishes to conduct a small study using cannabis or some other narcotic substance, the Party must ensure that those small amounts are accounted for through the estimate and statistical return system. If distributors or dispensers (in any State authorizing it) could cultivate and distribute cannabis on a physician’s advice, this entire system would rapidly become disrupted and meaningless.

122. INCB press release (Feb. 8, 2008).

123. See 21 U.S.C. § 801(7) (findings).

124. Congress has recognized that our international treaty obligations can actually “trump” the normal scheduling process. Generally, in that process, the Attorney General (delegated to the DEA) is bound by DHHS’s and FDA’s medical and scientific evaluation of, and recommendations upon, certain statutory criteria relating to scientific knowledge, pharmacological effect, and abuse potential. However, if control is required by the United States ’ obligations under international treaties, the Attorney General must issue an order controlling the drug under the schedule he or she deems most appropriate to carry out such obligations, without regard to any of the findings described above. 21 U.S.C. §811.

125. Gonzales v. Raich, 545 U.S. 1 (2005).

126. It should be noted that the federal government first intervened in cannabis dispensaries under President Clinton’s administration. See U.S. v. Oakland Cannabis Buyers’ Cooperative (2001) 532 U.S. 483 (no exception for “medical necessity” under the CSA for distribution of cannabis for medical purposes).

127. In 2007, the DEA sent notices to landlords in California warning them that their property could be seized if it were being used for the purpose of marijuana distribution. http://www.safeaccessnow.org/downloads/DEA_Landlord_Letter.pdf.

128. Some dispensaries boast a “membership” of 20,000, with hundreds of new “customers” signing up monthly. Manhattan Project, supra.

129. See, e.g., The Green Cross. http://www.sanfranciscocannabisclubs.com/directory/san-francisco-green-cross.htm.

130. Even the mayor of San Francisco does not support the legalization and “regulation” of cannabis for non-medical use. See, “Legal Pot is Not Mayor’s Cup of Tea,” San Francisco Chronicle (Feb. 27, 2009).