Monday, August 24, 2009

MCSC Nomenclature Report

Executive Summary

            The naming of cannabis medicines is an important factor in creating a professional and positive perception of the industry. There are many areas which need to be standardized in order for us to grow collectively and represent our goals and ideals in a clear and accurate manner. The goal of this report is to study the many resources available and choose the best nomenclature for the current environment in California as well as the other medical cannabis states which are evolving and growing. We are embarking upon a new era of governance that we hope will be more accepting and honest in in regard to cannabis therapies. To best explain the standards and practices of the cannabis medicines industry it is necessary to set proper terminology for reference purposes.

            This study is expansive, reaching the far corners of the globe, and includes the long history of cannabis medicines and the current state of affairs in the global environment. An internal survey of people directly involved with the medical cannabis movement is also included. This survey is a good measure of what are seen as acceptable terms in the medical cannabis community, based on the short history of the industry’s growth in America. This report also examines the many practices of international entities and governing bodies, including Health Canada, The European Commission, The Netherlands’ Office of Medicinal Cannabis, the World Health Organization, and the International Conference on Cannabis. It also examines terms used in America by the Food and Drug Administration, the U.S. Pharmacopoeia, The State of California, and some other valuable resources.

            None of the models we studied has a complete set of universal terms that would easily transfer to the situation we face. By compiling and choosing relevant information from many sources we can begin to make informed and well-thought recommendations on which to base our structure. This report will detail the findings from these organizations and entities, and make a set of nomenclature recommendations to narrow down and hopefully reach consensus in order to continue moving forward.

            This purpose of this report is to create a framework which the many patients and providers of cannabis medicines can look to as a resource to help structure their efforts in a consistent and professional manner. In order to be recognized as a legitimate force in the health care industry it is necessary to operate in a cohesive manner. That effort begins with the way we reference cannabis medicines, the methods of production, the methods of distribution, and the methods of use. This survey is meant to be a definitive guide and the results will not necessarily represent the final recommendations of the Nomenclature Committee, nor the MCSC. Nonetheless by creating such standards the industry can begin to open the hearts and minds of medical professionals, regulatory authorities, and society as a whole to be more accepting of cannabis therapeutics and the practices associated with them.

Introduction

            The Nomenclature Committee has four basic tasks to better define the cannabis medicines industry. The first is defining proper classification names for the many different types of cannabis medicines, including raw plant material, extracts, and other common derivatives of cannabis. This task also includes terms of reference for producers and providers of these medicines. The second task is developing a standardized naming guideline for cannabis medicines. It is important to find a more professional manner to identify the many types of cannabis and to move away from some unprofessional and comical practices in current use. The third and fourth tasks involve developing labeling and packaging practices to clearly convey this information to the end-user, the patient. The many findings in this report will touch on what is currently done in other areas of cannabis therapies, what has been done historically, and what could be applied to the current state of affairs in medical cannabis states.

What the Community Thinks (Survey)

            We conducted a survey on nomenclature, reaching out to patients, providers and activists on many online forums and lists. This feedback produced some very interesting findings and provides a great deal of insight into some areas of consensus, as well as some areas of confusion. The survey touched on naming concepts for different medicine types, ideas for clarifying strain names and labeling matters, and thoughts on packaging requirements.

            The community consensus was that the term “Whole Plant Medicine” most accurately described Cannabis in a broad way to include the entire Cannabis plant. The term “plant material” was the second choice. Some other good ideas submitted were whole cannabis plant, medicinal plant, and simply Cannabis. This term is important, as it is the basis for the entire industry. All cannabis medicines are derived from the “whole plant” experience.

            Two terms for describing the “fruit,” more commonly referred to as “buds,” of the Cannabis plant garnered fairly equal support: “flowers” and “buds” ran neck-and-neck in the polling with “flowering clusters” running about 10 percent behind them. Some other good ideas submitted were flowering tops, primary material, female flowering tops, and blossoms. These products are the predominant form of cannabis medicine used by far. Defining a responsible term for them is of paramount importance to our efforts to change the perception of medicinal cannabis.

It is also important to define the term used for a person who produces these medicines, such as patient cultivator or medicinal plant producer.

            When describing the by-product or “trim” of the plants, that is often used in extraction and processing of other medicines the terms “trim” or “trimmings” were the overwhelming choices of those surveyed. “Secondary Material” and “Leaf” were the next nearest, though far behind trim. Other good ideas submitted were “foliage,” and “byproduct.”  This term is also important, as it is a primary ingredient in most medicines derived from cannabis.

            The stems of the plant are not widely used, but are sometimes referred to and used in some preparations. The simple term “stems” received an overwhelming 80% of the choices. Some interesting ideas submitted were “cellulose fiber,” “stem byproducts,” and “woody material.”

            There was an interesting result regarding hashish. When describing the term in general manners the majority of folks believe “concentrate” is the best term, but when asked to describe the different types of hash, such as water and gas processed products, the consensus was that “extraction” was the best choice. Some other terms for hash were “resins,” “concentrated material,” and “concentrated trichomes.”  Hashish is a product which needs to be defined clearly, as it is often the subject of scrutiny by governing bodies. The community can dispel myths of irresponsibility, and open people up to viewing extractions as efficient medicine for patients, by creating a standardized and professional term for this type of medicine.

            Cannabis foods are often misrepresented by the media, by enforcement agencies, and others outside the community. The truth is that ingestible products are one of the safest forms of cannabis medicines as there are no carcinogens being burned and no hot gases to otherwise disrupt lung tissue. The effects are also different from normal inhalation methods of ingestion, that can be beneficial to many patients. The term “food-based medicine” for this product was the favorite choice of those surveyed, with the term “edible” about 6 percent behind. Some other good terms suggested were “nutritional medicines,” “food supplements,” and “medibles.”  Defining these medical food products is essential to their survival in the regulatory process. Alameda County has banned “edibles” at county-regulated facilities. This term “edibles” is one which our community has already adopted and which is being used by some governing authorities. By changing the term to “food-based medicines,” we may change the perception of these products and more clearly define their benefits. There are many medicinal foods available worldwide; it is an emerging industry that we in the cannabis community should follow closely.

            The term “kief” was a clear choice amongst participants for describing what is commonly known as “kief,” the loose resin glands shaken from plant products and ordinarily refined in a screening filter. “Resin Glands” was a distant second. Some other ideas proposed were “dry sift,” “loose resin gland concentrate,” and “dry hash.”  The alternative spelling of “kif” was also suggested. This product is often overlooked by regulators and lumped in with hash products by enforcement agents, but kief can be a very powerful and effective medicine and ingredient in other medicinal products. The way in which this product is named and classified is essential to it being recognized as a legitimate form of cannabis medicine.

Tinctures are often overlooked, as they make up a small portion of the market. Yet cannabis tinctures and elixirs, which were popular at the turn of the century according to the US Pharmacopoeia, are still effective methods today. It is interesting to speculate whether they should be considered an “edible” product or a “concentrated” product. Tinctures are a staple in alternative and herbal medicine supplies and can be made with a number of bases, including alcohol and glycerin. The term “tincture” is a common clinical term for these products, so it is no surprise that this was chosen by an overwhelming majority of participants. These methods of ingestion are essential for many patients, as it allows them to add cannabis essence to beverages or food, and otherwise medicate in an easy-to-consume way. This is extremely important to patients that are working through chemotherapy and wasting as the medicine can be consumed in a mostly unobtrusive manner, and it can take effect rapidly.

            An aspect of nomenclature which is a source of controversy in the cannabis medicine industry is the naming of strain types. Lack of guidelines or regulations has left the door open to individual interpretation. Rolling Stone and other media have in the past exploited some of the more comical or unusual names in order to sensationalize journalistic pieces on the industry. This can create a negative perception of the industry. Some in the public may be offended or skeptical that terms like “Pussy Kush” or “Catpiss” would be used to describe medication. The survey posed the question: “When naming individual cannabis strains what methods could be used to create a system that is more professional in nature and acceptable to societal standards?”  The choices varied from a “coded system” detailing characteristics such as plant fractions and genetics; an “abbreviated system” that would simplify common names into recognizable abbreviations; an “appearance-based system” that would classify medicine into sight and smell based names; or a “simple guideline system” disallowing unethical, pandering, or “humorous” names. The majority of the people surveyed believed that a detailed coded system would be the best option. Not far behind in the voting was the choice to create simple guidelines which allow collectives to name medicine within a clear set of boundaries. Other positive suggestions were to develop gene mapping and DNA ability for strains, using the best scientific and common names available, and naming the medicines based upon actual measured percentages of indica and sativa genetics. This issue is extremely important as it is at the core of the perception of our industry. It is difficult to be taken seriously by medical professionals and regulators when some cannabis medicine names sound childish and comical. Finding a method by which providers can clearly define their medicine type without having to use unprofessional terms will be an important step in creating a more positive perception of the industry.

            Dealing with proper labeling requirements for the many different types of cannabis medicines is also a major part of regulating this industry. Deciding what labeling information is necessary for cannabis medicines will also help to better inform patients and will give providers a framework for providing necessary information to patients. Respondents were surveyed regarding labeling of raw flowers, extractions, food-based medicines, and topical productions.

            The majority believed that type of medicine, production method, manufacturing date, packaging date, and potency were extremely important components that should be on the label for raw flowers. Surprisingly, not many believe that drug facts panels, prominent warnings, list of potential contaminants, or growth term were of much relevance. Other suggestions included net weight, recommendations for day or nighttime use, and curing period.

            The labeling recommendations for extracts were similar to those for raw flowers, not surprising as they are both commonly used in similar manners. People saw a need for labeling to indicate medicine type, production method, manufacturing dates, and strength. Only about half of respondents believed that prominent warnings, possible contaminants, and packaging date were of importance. Drug facts were only deemed necessary by about one third of those surveyed. Also deemed important were suggested use, ingredients, and net weight.

            Food-based medicines seem to get a more rigid response, as most categories listed were chosen by at least two-thirds of participants. One could speculate that there is a perception that the danger is greater with food-based medicines than with other forms of cannabis medicine. Type of medicine used, expiration dating, medical vehicle, ingredients, and dosage were all overwhelmingly chosen as necessary information for edible labels. Most people also saw nutritional values, allergens, usage, storage instructions, and warnings as important. Drug facts was the only category that most participants saw as unnecessary. This could suggest that respondents were unsure of what “Drug Facts” panels are and what purpose they serve. Other suggestions were to declare if it was made with bud or leaf, if it is organic or non-organic, and net weight.

            Topical medicines were also seen as requiring more label information. Type of medicine used, expiration dating, base product, ingredients, usage instructions, storage needs, and dosages were all chosen by the majority of those surveyed as needed information on a label. Warnings, packaging date, and allergens were also deemed important, by a smaller percentage of the group yet still a majority. Drug facts was the only item not receiving a majority vote. Notably, some respondents did not believe in the use of cannabis topical medicines.

            What is on the label of cannabis medicines is extremely important. It is often the only information a patient will have about that particular medication. It also protects the provider by clearly defining the medicine and its suggested uses. In terms of patient safety there may be no better way to convey information than through the packaging of the actual medicines used. Deciding on necessary labeling information for each kind of cannabis medicine enables the industry to develop clearer protocols for providing these medicines.

            The final question concerned packaging of cannabis medicines. The four choices made available were full tamper-resistant packaging, tamper-evident methods, packaging promoting freshness but not required to seal, or no packaging regulations at all. Tamper evident packaging, such as paper or sticker seals that could be seen if broken received the most votes (44%). Full tamper-resistant regulations, and packaging which promotes freshness but does not seal, both received an equal number of votes (30% each). Only 18% supported having no regularion of packaging.

Packaging of cannabis is important for a number of reasons: assurance of freshness, protection from contamination, and discouraging unintended use of the medicine. Packaging cannabis medicines in a manner consistent with societal expectations of medicinal packaging could make those who currently oppose cannabis therapies more open to their use, as well as creating an environment of patient safety and satisfaction.

            This survey was conducted with over one hundred and fifty activists and medical cannabis stakeholders. While a relatively small sample, the results provide a good measure of the community’s perception of the current state of affairs and where they would like to see the movement progress. The community will be implementing these standards, so finding out what this sample sees as optimal choices regarding the many nomenclature issues surrounding medical cannabis will help the community to make more clear and informed decisions.

What Terms Do Other Agencies and Organizations Use?

            Vast amounts of material from agencies and organizations which have established terms of reference for cannabis and other herbal medicines have been researched and analyzed in order to come up with language which is relevant to our industry. The following are findings from these organizational practices and ideas:

European Union/European Commission

            The European Union does not officially regulate cannabis medicine in any manner. Most countries in Europe have yet to allow the use of cannabis medicines. The EU has an extensive program regulating use of herbal medicines which could serve as a model for this project in creating standards for production, storage, processing, documentation, and quality control in the cannabis industry. There are also terms which may be adopted and adapted to the medical cannabis industry.

            Plants used in the creation of herbal medications are referred to as “Medicinal Crude Plants” In their whole-plant state This term acknowledges the plant as medicinal though it is in a crude, raw form and can thus be further refined for medicinal purposes. EU documents refer to some preparations as “extracts” or “extractions,” and “tinctures.” They refer to “concentration stages” in requirements for documenting the processing of medicinal crude plants into products such as “liquids, creams, and ointments.” The EU requires that producers clearly identify whether the “whole plant” or only part of the plant was used in the refinement process. “Starting material” is a term repeatedly used in the EU’s documentation process in relation to “finished products.” The term used for finished products is “vegetable drug preparations.”

            There are references to cannabis on EU websites, but not in relation to any regulatory processes. They seem to be very in line with terminology used by the World Health Organization, and many related materials from the EU overlap with terms used by the WHO. They refer to the botanical name of the plant, Cannabis sativa, and refer to its preparations as “teas, hash, or resin.” These terms could be adopted and adapted as appropriate nomenclature by the more advanced organizations in regulating herbal medicines. Furthermore, these sound EU policies can serve as a blueprint of global expectations for regulating the methods and processes by which herbal preparations are created.

Netherlands: Office of Medicinal Cannabis

            The Netherlands may have the most advanced program for actual regulation of medicinal cannabis. Its program is inclusive, as only three companies make medicinal-grade cannabis for patient consumption. The Netherlands is widely known for its tolerance of cannabis in a more social (i.e. non-medical) environment yet the production methods used in creating cannabis medicines are taken very seriously.

            The producer of “Bedrocan” details their production methods, highlighting the extremely sterile and environmentally-friendly regulations they have for producing cannabis. They explain that hygiene is their number one method for avoiding plant contamination. Thorough, daily inspection of garden areas and use of only cleaning solvents which leave no residue are important elements in their production process. They go into great detail about the importance of not afflicting the environment during production, highlighting their use of energy-efficient lighting and climate control, recycling rock wool to make roads, and methods by which they dispose of wastewater. These ideas provide great models for possibly reducing the environmental impact of producing cannabis medicines.

            The terminology used by the Netherlands is of major interest as they represent the most advanced system currently available. They use the simple term “Cannabis” when referring to the plant in whole form. They describe the medicinal product of cannabis as “dried flowers of the female cannabis plant.”  There is an ongoing debate as to whether cannabis is a “magisterial preparation,” which is prescribed and covered by national insurances, or if it is a “standardized preparation,” much like over-the-counter medications here in the US, that would not be covered by insurances. At present, national insurance providers in the Netherlands cover most cannabis medicines.

            The Office of Cannabis Medicines prohibits any claim that any cannabis medicines are organic, thus resulting in the use of the term “bio” by producers. The Office also also the term “cannabis resin” for extracted preparations commonly known as hashish. They have two recommended “methods of administration”: “oral” and “inhalation.”  They even have a recipe for making a cannabis-based tea, in which they recommend adding milk to the tea if storing it to bind the medicinal properties of the cannabis.

            They use the term “dried inflorescences” for flowers in their labeling process and refer to “absorption rates” in their instructions for use. Their labeling requirements for cannabis medicines are extremely detailed and give the patient a great deal of information about their medicine. The labels detail the “appearance, identity, microscopy, fineness, absence of pesticides, foreign material, and mold and aerobic bacteria contents.”  They clearly specify the results of “thin layer chromatography,” defining the levels or lack of many elements including lead, mercury, cadmium, dronabinol, cannabinol, and other related substances. They even detail the moisture content and expected loss on drying. Their “assay” section goes into detail about the many active ingredients and they use the term “fingerprint” in discussing the monographic similarities of the medicine.

             The program in the Netherlands may be more advanced than is practical for California in the introductory stages of labeling cannabis medicines as appropriate testing is not yet available on a large scale, yet it is important to envision the future and begin looking more deeply into these processes. “Specifications” are given with each 5-gram allotment of medical cannabis to ensure that patients are well informed about the properties of their medicine. There are many areas of information, such as appearance and microscopy, which could immediately be applied in California’s current environment and be given to the patient with their medicine in order to address some of the safety concerns and labeling practices of cannabis medicines.

            A clearer understanding of what is expected of medical cannabis companies which are currently regulated in the Netherlands can help provide a window into what may be expected of producers of cannabis medicines here at home. Replicating portions of this detailed program where feasible may help provide assurances into the safety of cannabis medicines and create better understanding among medical professionals, regulators, and concerned citizens who use the lack of safety regulation in the manufacturing process to excuse their lack of support of cannabis therapies.

International Association of Plant Taxonomy and Small and Cronquist

            The International Association of Plant Taxonomy in association with the Royal Gardens in the United Kingdom declared that this subject had virtually lain dormant since the 1970s. They submitted as the most common reference a study done by Small and Cronquist in 1976, “A practical and natural taxonomy for Cannabis.” This is a highly debated study, as Small and Cronquist claim that there is one “single, highly variable species” of cannabis, Cannabis sativa. They claim that the many seemingly different “types” or “strains” of cannabis are the results of genetic selection that have evolved due to “morphological and geographical conditions, chemical induced features, features of cytology and breeding behavior as essential specific criteria, and phenotypic data.” 

            They claim that there are three common “species” of cannabis, being C. sativa, C. indica, and C. ruderalis. They refer to three types of “cannabis drugs” in their work. They refer to “marihuana, hashish, and hashish oil” as common forms of these drugs. They repeatedly refer to cannabis as being “wild or domesticated,” and refer to “taxonomic delimitation” as the reason for the many different types of Cannabis sativa. There are many short writings in opposition to Small and Cronquist’s research and conclusions, but as Cannabis is largely a prohibited drug little work has been done in this area. It is significant that this study was done shortly after the Controlled Substance Act was enacted in the US. Also, the Psychotropic Substances Act of 1978 which amended the CSA to conform to United Nations treaties stifled the research on this subject. As a result, Small and Cronquist’s outdated and subjective material is the most in-depth “bona fide” study of the species of Cannabis sativa.

International Conference On Cannabis

            The International Conference on Cannabis issued a detailed report on their findings which included some very useful terms. They referred to “whole plant preparations” as being more beneficial than “isolated substances” such as dronabinol or CBN alone. They repeatedly refer to “raw material” and refer to the “dosage form” as a very important aspect to cannabis therapy. The ICC briefly touches on the different “cannabis preparations and products,” including “hashish.” Potency levels range from “very strong, to strong, to moderate, and mild.” Their preferred term for cannabis flowers is “sinsemilla blossoms,” and they acknowledge the many “variations” of the cannabis plant. These terms are used by some of the leading researchers in the field of cannabis studies and carry scientific weight. These terms are quite useful when looking at the industry through the scope of researchers and medical professionals.

Health Canada

            Health Canada is the government agency regulating the developing medical cannabis industry in Canada. This government agency is currently revising its policies and recently changed its distribution practices. When Canada’s program began, HC contracted with one company to grow its cannabis. They had less than stellar results and have since revamped their system to allow independent producers to apply for a “License to Produce” which can even be done in an “ordinary place of residence.”  They use the term “marihuana” in most of their documentation, often referring to the botanical name Cannabis sativa L. “Indica” in their descriptions. Common terms are “dried and milled marihuana or cannabis plants.”

            Their strain allocation is referred to in a very scientific sounding “hybridization of MS-17/338 and MS/17/596” which is most likely a code of some sort, but at the time of this writing has yet to be confirmed by a representative of Health Canada. They send “seeds” of this strain to those with a valid license to produce. The plants’ appearance is described in their patient information literature as “dense, conical, resin laden flowering heads.”

            Health Canada allows use of cannabis for patients with symptom categories of 1, 2, and 3. Symptom Category 1 refers to the most serious afflictions, Symptom Category 2 refers to less serious conditions requiring more than one professional recommendation, and Symptom Category 3 are the least serious afflictions requiring multiple opinions and sworn affidavits that all other options have been exhausted. They refer to cannabis in terms of “conventional treatment” for some symptoms and serving a “medical purpose” for other afflictions.

            In dealing with cultivation Health Canada refers to “production areas or sites” and requires the producer to clarify if the product is grown “indoors, outdoors, or partly indoors/outdoors.” They require that the producer define the “form” in which the medicine is produced and the suggested “route of administration” for patients. A patient is required to apply for an “Authorization to Possess.” Those holding a license to produce are subject to searches by regulators and law enforcement at any time to ensure compliance with the program’s standards and regulations. They also have an intricate method of deciding how much medicine can be produced by calculating a patients “daily required dosage” in grams in conjunction with the “growth cycle of a marihuana plant from seedling to harvest” to determine the maximum number of plants a producer may grow at any given time.

            The “specification sheet” which accompanies cannabis medicines delivered to patients is extremely detailed, much like those in the Netherlands program. The sheet includes categories for “strain (selected line), description (mature flowering heads), thc level, and moisture content.”  They provide a detailed leaflet to patients which includes “storage instruction, more detailed plant description, cannabinoid levels, chemical profile, physical identity, pesticides (if any), foreign materials present, chemical identity, potency levels, metals and heavy metals (if any), microbiological purity, aflatoxins, and general information.”  For seed shipments, the germination process is defined as well. These details may be impractical in the current medical cannabis environment in America, but can serve as a possible roadmap for the future. Learning to adhere to as many of these practices as possible will provide the patient with more information for their well-being and will address concerns of those interested in the safe production and handling of cannabis medicines.

World Health Organization (WHO)

            The World Health Organization is a leader in the advancement of herbal medicines and recognizing the need to regulate these types of therapies. Many of their terms are similar to those used in the European Commission section so more general terms for herbal medicines need not be repeated here, yet they do have some important, definitive terms regarding cannabis.

            For the most part the WHO refers to marijuana simply as “cannabis.” They refer to THC as being the “major psychoactive constituent” in cannabis. They use the term “crude plant material” to refer to cannabis in its raw form. Their references to cannabis preparations include “hashish, cannabis oil (hashish oil), and concentrate of cannabinoids.” They refer to methods of “solvent extraction of crude plant material in the making of resin.” The WHO clearly states that its contention that lower prices of cannabis lead to more abuse, yet they do recognize that “therapeutic uses of cannabinoids are being demonstrated by controlled studies, including treatment of asthma and glaucoma, as an antidepressant, appetite stimulant, anticonvulsant and anti-spasmodic, research in this area should continue.”

            The World Health Organization is a highly respected global agency which has done a great deal of work confronting the challenges faced in the declaration of all herbal treatments as medicines, working to develop sound practices and standards for their production and uses. The model they set forth is extremely detailed and will most likely become the international standard for producing herbal medicines, as society grows to accept these natural forms of medicine, cannabis included. It would be beneficial to begin adopt, adapt, and implement certain of their practices in the standards and guideline being developed here in California.

FDA Definitions for Controlled Substances

            The US Food and Drug Administration draws its terms for cannabis from the Controlled Substances act. They refer to “marihuana” as “all parts of Cannabis sativa L., whether growing or not.”  The act refers to “seeds,” and “resin extracted from any part of such plant.”  It defines for legal purposes “every compound, manufacture, salt, derivative, mixture, or preparation of such plant” in order to fully encompass the meaning of cannabis and the many methods of its use. They use the term “agent” in describing a “manufacturer, distributor, or dispenser” of controlled substances of any kind. The terms defined for methods of using controlled substances are “injection, inhalation, ingestion, or any other means by which a substance can be taken.” They define the term “manufacture” as the “production, preparation, propagation, compounding, or processing by extraction from substances of natural origin.” These are legal terms used for all medicines and drugs, and are associated with the use and manufacturing of controlled substances. The terms are very relevant because they are used by the US Food and Drug Administration, which could ultimately be the agency responsible for classifying, scheduling, and regulating the medical cannabis industry in the US.

U.S. Pharmacopoeia Verified Program for Dietary Supplements

            The U.S. Pharmacopoeia Verified Program directly addresses the need to better regulate the herbal products industry. They claim that products carrying their verified logo have been thoroughly tested and adhere to high levels of “integrity, purity, dissolution, and safe manufacturing.” The USP recognizes “botanical extracts” as a valid form of therapy and all supplements must adhere to their “rigorous program requirements.” They guarantee that products they verify are “consistent in quality from batch to batch,” and that they have conformed to an “accepted manufacturing process.” Herbal products are tested for “acceptable levels of contamination” and are tested to verify the “certificate of analysis claims” for each product. Recognized product types are “caplets, hard gelatin capsules, liquids, powders, soft gelatin capsules, tablets, and teas.” Their labels must contain a minimum of “product name, official name: finished product, item code numbers, bulk product code numbers, and product specifications in detail.” This organization’s focus on voluntarily verifying and certifying these lightly regulated herbal products does not entirely transfer to the system of cannabis medicines, but their principles and methodology are extremely relevant to the self-regulatory model which the cannabis industry may have to implement.

State of California

            The State of California has terms associated with medical cannabis from the Compassionate Use Act (Prop. 215) and State Bill 420. Some useful terms are “qualified patient and primary caregiver” in defining who may lawfully possess cannabis medicines. The “serious medical conditions” for which cannabis is allowed to be used in California are “AIDS, Anorexia, Arthritis, Cachexia, Cancer, Chronic Pain, Glaucoma, Migraine, Muscle Spasms (MS), Seizures (Epilepsy), Nausea, Chronic or Persistent Medical Symptoms.” California medical cannabis laws refer to “dried marijuana and dried mature flowers of female plants.” They use the term “smoke or otherwise consume” in referring to ingestion methods. The terms “cultivate or distribute” are used to refer to methods of providing cannabis. The former California Attorney General Bill Lockyer referred to “concentrated cannabis or hashish,” in his opinion that concentrates be treated in the same manner as raw cannabis. These terms are important, as they are the definitions currently being used to describe cannabis therapies in the legal process in California. Learning to use these terms or adjust them where necessary is helpful in addressing an audience of could be regulators in the future.

Conclusion

            No clear “correct” nomenclature and standards have yet been set for the emerging medical cannabis industry. We have the opportunity to make informed decisions and recommendations in order to create better understanding among the community. Standards are necessary for a number of reasons. Providing clarity to patients ensures a safer environment in which to access cannabis therapies. A clear message in our collective communications will encourage regulators to adopt our terminologies and base their decisions on information that is reasonable and accurate in nature. Creating a perception of professionalism and having a more consistent attention to detail will help to open the hearts and minds of medical professionals, hesitant patients, and opposing agencies which are merely misinformed about cannabis medicines and their history of safe use.

            The terms recommended by the MCSC can help provide appropriate structure to the broader community as the industry promulgates standards. Ideally all dispensing collectives, patients, and providers of medicine would adopt such standards, thus providing clarity and unity for the industry. Official recommendations will be vetted thoroughly by the community and will represent the ideals and principles toward which we want collectively to move. Mastering the language associated with the industry and its many stakeholders is vital for providing a clear framework on which to build. Cannabis is the medicine of the future. We must begin to clarify our expectations for the many people involved in the medical cannabis continuum, from plant to patient. It is hoped that as the industry moves forward this report will spark a dialogue about the nomenclature issues facing the community.

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