By Tegan Adams, Michael Bertone

When a cannabis sample is submitted to a lab for testing there is a four-step process that occurs before it is tested in the instrumentation on site:

It is ground at a low temperature into a fine powder;
A solution is added to the ground powder;
An extraction is repeated 6 times to ensure all cannabinoids are transferred into a common solution to be used in testing instrumentation.
Once the cannabinoid solution is extracted from the plant matter, it is analyzed using High Pressure Liquid Chromatograph (HPLC). HPLC is the key piece of instrumentation in cannabis potency testing procedures.

While there are many ways to test cannabis potency, HPLC is the most widely accepted and recognized testing instrumentation. Other instrument techniques include gas chromatography (GC) and thin layer chromatography (TLC). HPLC is preferred over GC because it does not apply heat in the testing process and cannabinoids can then be measured in their naturally occurring forms. Using a GC, heat is applied as part of the testing process and cannabinoids such as THCA or CBDA can change form, depending on the level of heat applied. CBDA and THCA have been observed to change form at as low as 40-50C. GC uses anywhere between 150-200C for its processes, and if using a GC, a change of compound form can occur. Using HPLC free of any high-heat environments, acidic (CBDA & THCA) and neutral cannabinoids (CBD, THC, CBG, CBN and others) can be differentiated in a sample for quantification purposes.

Near Infrared

Near infrared (NIR) has been used with cannabis for rapid identification of active pharmaceutical ingredients by measuring how much light different substances reflect. Cannabis is typically composed of 5-30% cannabinoids (mainly THC and CBD) and 5-15% water. Cannabinoid content can vary by over 5% (e.g. 13-18%) on a single plant, and even more if grown indoors. Multiple NIR measurements can be cost effective for R&D purposes. NIR does not use solvents and has a speed advantage of at least 50 times over traditional methods.

The main downfall of NIR techniques is that they are generally less accurate than HPLC or GC for potency analyses. NIR can be programmed to detect different compounds. To obtain accuracy in its detection methods, samples must be tested by HPLC on ongoing basis. 100 samples or more will provide enough information to improve an NIR software’s accuracy if it is programmed by the manufacturer or user using chemometrics. Chemometrics sorts through the often complex and broad overlapping NIR absorption.

Bands from the chemical, physical, and structural properties of all species present in a sample that influences the measured spectra. Any variation however of a strain tested or water quantity observed can affect the received results. Consistency is the key to obtaining precision with NIR equipment programming. The downfall of the NIR technique is that it must constantly be compared to HPLC data to ensure accuracy.

At Eurofins Experchem , our company works with bothHPLC and NIR equipment simultaneously for different cannabis testing purposes. Running both equipment simultaneously means we are able to continually monitor the accuracy of our NIR equipment as compared to our HPLC. If a company is using NIR alone however, it can be more difficult to maintain the equipment’s accuracy without on-going monitoring.

What about Terpenes?

Terpenes are the primary aromatic constituents of cannabis resin and essential oils. Terpene compounds vary in type and concentration among different genetic lineages of cannabis and have been shown to modulate and modify the therapeutic and psychoactive effects of cannabinoids. Terpenes can be analyzed using different methods including separation by GC or HPLC and identification by Mass Spectrometry. The high-heat environment for GC analysis can again cause problems in accuracy and interpretation of results for terpenes; high-heat environments can degrade terpenes and make them difficult to find in accurate form. We find HPLC is the best instrument to test for terpenes and can now test for six of the key terpene profiles including a-Pinene, Caryophyllene, Limonene, Myrcene, B-Pinene and Terpineol.

Quality Systems

Quality systems between different labs are never one and the same. Some labs are testing cannabis under good manufacturing practices (GMP), others follow ISO accreditation and some labs have no accreditation at all.

From a quality systems’ perspective some labs have zero or only one quality system employee(s). In a GMP lab, to meet the requirements of Health Canada and the FDA, our operations are staffed in a 1:4 quality assurance to analyst ratio. GMP labs have stringent quality standards that set them apart from other labs testing cannabis. Quality standards we work with include, but are not limited to: monthly internal blind audits, extensive GMP training, yearly exams and ongoing tests demonstrating competencies.

Maintaining and adhering to strict quality standards necessary for a Drug Establishment License for pharmaceutical testing ensures accuracy of results in cannabis testing otherwise difficult to find in the testing marketplace.

Important things to know about testing

HPLC is the most recommended instrument used for product release in a regulated environment.
NIR is the best instrument to use for monitoring growth and curing processes for R&D purposes, only if validated with an HPLC on an ongoing basis.
Quality Systems between labs are different. Regardless of instrumentation used, if quality systems are not in place and maintained, integrity of results may be compromised.
GMPs comprise 25% of our labour costs to our quality department. Quality systems necessary for a GMP environment include internal audits, out of specification investigations, qualification and maintenance of instruments, systems controls and stringent data integrity standards.

September 6, 2016

Quality From Canada

The Devil is in the Detail – Changes to Canada’s Cannabis Regs to Encourage Patient Independence and Business Competition

By Tegan Adams, Elfi Daniel-Ivad MSc

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Canada’s new ACMPR was launched late last month on August 24^th. The key change that most notice is that Canadians may now again grow their own cannabis at home for medical purposes. In addition, more strict guidelines for product testing and labeling requirements for Licensed Producers (LPs) were released.

Short term pain for long term gain. While the combination of allowing patients to grow at home and more strict regulations for LPs may at first seem like a business disadvantage; overtime LPs will be thankful for the combination switch. Health Canada’s new requirements encourage a leveling of the playing field globally between LPs and large scale product manufacturers of pharmaceuticals, therapeutics and natural health products. The steps Health Canada is taking to regulate our producers, is exactly what they need to get ready for mass production that will be necessary for recreational markets, scheduled for release in Spring 2017.

Picture rows of Tylenol bottles on the shelf at your favorite pharmacy. Now picture rows of cannabis bottles on the shelf beside them. This is what medical cannabis will look like in Canada perhaps as early as 2018, if not sooner. With just under forty LPs on the map and a projected sales volume of modest billions, Canada’s LPs’ eyes are widening with dollar signs as they lube up their oil production and more to see what shelves in Canada will hold.

Curious to know more? Our regulatory department manager Elfi Daniel-Ivad is an expert in regulatory change. She has worked on close to 150 submissions for cannabis licensees in Canada and beyond. Here are a few key changes from her department’s overview to better understand.

MMPR	ACMPR (Updated)
No personal production or designated production available to patients (aside from that grandfathered in by MMAR).	Personal production and designated production available. Patients may grow 5 indoor plants OR 2 outdoor plants at any given time per gram prescribed to them.
Licensed Producers were not required to label THC or CBD amounts in dried cannabis, though most producers did for sales and educational purposes. Oils had to be labeled with THC and CBD amounts.	Licensed Producers must label their percent THC and CBD for dried and fresh cannabis products.
For the labelling of oils, the total quantity of THC, CBD and oil in a container had to be shown. Restrictions on THC allowed no more than 10mg/mL THC per capsule and no more than 30mg/mL THC per mL oil to be distributed.	In addition, oil labels must now include information on “carrier” oil and allergen information. Containers must be labelled with number of capsules, the net weight and volume of each capsule. .
No reference to validation of analytical testing methods.	Analytical testing must be completed using validated testing methods; confirming reliability and consistency in results for contaminants, disintegration, residues and THC, THC-A, CBD and CBD-A
Accredited labs can only test products as received from Licensed Producers.	In addition to Licensed Producers, patients growing their own or having a designated grower growing for them may also test their products at an accredited lab.

In addition to these changes, it is important to note that if an individual or company has an MMPR proposal already submitted they can now revise it to include oil production (previously, it was first dried bud only). If a company submits a new ACMPR proposal, they can include oil production on their application right away. Interested in submitting your own application? Or need help with one in the USA? Our regulatory department would be happy to answer any questions you might have about the process.

August 23, 2016

Quality From Canada

Hold on for Rec! Canada’s New ACMPR Program

By Tegan Adams

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Earlier this month, Health Canada, in a press release, gave a glimpse as to what the new Access to Cannabis for Medical Purposes Regulations (ACMPR) might look like. On August 11^th, they announced the new set of regulations would go into effect on August 24^th this week. Information presented was not shocking. Most Canadians had hoped and suspected that the announcement would include a provision for growing cannabis at home – and it did exactly that.

Essentially, the ACMPR expands accessibility of cannabis from our highly regulated 34 licensed producers (LPs) to include those authorized by their health care practitioner to access cannabis. Anyone with the appropriate medical documentation can now grow for him or herself at home, or designate a grower to do so for them. Health Canada also stipulated in the press release that “Storefronts selling marijuana [sic], commonly known as ‘dispensaries’ and ’compassion clubs’ are not authorized to sell cannabis for medical or any other purposes.” The regulatory body went on to add: “These operations are illegally supplied and provide products that are unregulated and may be unsafe. Illegal storefront distribution and sale of cannabis in Canada are subject to law enforcement action.”

There were a few curve balls in the announcement, including a statement issued that suggests commercial producers may be the only ones authorized to distribute seeds or plants to those growing for themselves or on behalf of another. It is unclear how the plant and seed sourcing aspect will be regulated and/or how that statement may impact LPs over individual producers. Restriction of strain availability and additional costs are examples of potential implications to individuals[1]. LPs therefore remain in control of the types of cannabis available on the market. It is unclear if this regulatory aspect will mean they can restrict access to strains they have on hand, or not, especially if they are popular for sales.

When the first glimpse of the ACMPR was released, we saw many LPs stock drop in price across the board, in some cases greater than 10%. It is not anticipated however that the ACMPR will cause any long-term negative effects on LPs stock price or profitability. The ACMPR was put in place merely to satisfy a court ruling on a deadline. The deadline was inconvenient, occurring around 9 months before the regulations governing recreational sales are meant to go in effect. It meant that Health Canada employees had to dedicate time to finding a Band-Aid solution up until recreational sales instead of focussing on recreational regulatory framework itself.

Recreational regulations are scheduled for release in 2017, and it is unclear when exactly they will begin. As they do begin to unfold it is projected that the production and sale of cannabis will remain highly regulated. LPs will remain the consistent quality source of supply. There have been multiple distribution models in discussion, including co-op retail ownership, pharmacy dispensary and liquor board models. While yes, those with medical documentation anticipate still being able to produce at home; it is unlikely this allowance will have any effect on the overall sales of LPs as the market unfolds. Alcohol and wine are good examples to compare the regulatory model to. While sure, any of us can do home brewing, odds are we would still like to purchase beer from commercial breweries. In both Vancouver and Toronto, property is very expensive. Higher percentages of the population are starting to live in apartments, condos and smaller homes. Many people working full time are not interested in growing their own cannabis and would prefer the variety of the marketplace. There are many reasons individuals will continue to purchase from LPs. As competition rises in the marketplace, so will efficiencies in production as producers become more familiar with growing practices. Canada is anticipating a drop in retail prices to be much more affordable than existing “black markets.” Cannabis will become commonplace on shopping corners and it will be a product that most will be able to afford.

July 12, 2016

Quality From Canada

Cannabis in Canada: 6 Key Considerations for Recreational Legal Distribution

By Tegan Adams

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Canada has been undergoing many changes in the cannabis marketplace, most notably in the last two years. Originally, the system began with increasing access to cannabis for those with medical conditions under a “grow your own” model, the Medical Marihuana Access Regulations (MMAR). After running for a while, our regulatory authority, Health Canada, decided that among other faults, the MMAR program could pose a security risk to individuals growing at home. Following the dissolve of the MMAR, later released was a set of regulations, called Marihuana for Medical Purposes Regulations (MMPR) to license commercial producers now called Licenced Producers (LPs). While some MMAR patients were grandfathered in, the MMPR began as the mainstream cannabis production platform. MMPR LPs are inspected with high security and quality standards to produce and distribute cannabis exclusively to medical patients with a doctor-prescribed medical document. Patients register with one LP exclusively and receive cannabis by a mail-order system, and mail order only.

Why mail order with a medical document? What about all the dispensaries selling cannabis across Vancouver and Toronto? Where is all this cannabis coming from, if the MMPR LPs can only distribute direct to a patient through mail order?

These are good questions. And they are questions you should be asking. There are a few different factors contributing to the vast array of consumer confusion across borders in the Canadian system. People are passionate about cannabis, as well as their own personal freedom to have it. Some are passionate for medical reasons, others for the pure punch of liberation. Either way these passions have resulted in an interesting series of court decisions including a more recent one that deemed the MMPR unsuitable to provide enough access to cannabis for those in need. Effective close to the end of August this year in 2016, the MMPR as it is currently written will cease to be in effect and require revisions or a new system entirely for the legislation to be accepted and continued with.

There are a few different critiques of the MMPR which include: not enough variety, no ability to “see and feel” products before purchase, limitations on supply sources, limitations on dosage formats (i.e. oil and dried flowers only) and some might try to argue the rise in cost. While cannabis remains illegal to traffic without adequate controls across Canada, it is low on the priority list for the RCMP to spend resources on. Depending on which town and situation you are caught carrying it in, you would be hard pressed to be charged for carrying cannabis unless you ask for it. So, Canada has seen a surge in retail dispensaries, licensed or not, at the municipal level to the point where hundreds of them now exist across the country, distributing hundreds of millions of dollars of cannabis products per year.

Dispensaries vary in degree of professionalism, prices and strains available. Some have over sixty strains while others hold only four or five. Because Health Canada does not require laboratory testing of these products, most do not know their cannabis’ potency or that it is safe from bacteria, moulds, pesticides and aflatoxins. If they wanted to know, they could not find out since those with Narcotics Licences for testing are unable to accept their products under any regulatory framework.

We have seen false and unaccredited labs pop up on street corners accepting the unregulated products, but what we have not seen is information on the methods these labs are using, how they are validated and whether or not they are accurate. Regardless, the general consumer base does not seem to mind. Many of these locations have been reportedly selling $20,000-$30,000 CAD per day per 5,000 square feet or less of an operation. That is on average $600,000 per month and if continued for a full year as some have done, around $7.2M per year. All unregulated, and all up until recently tolerated by our RCMP and local policy authorities.

Finally, given the industrial-scale distribution that was not just occurring in the black market anymore, different neighbourhoods that did not like cannabis complained. LPs complained. And other regulated product industry members complained. They all complained that the unregulated distribution of cannabis was negatively affecting them in one way or another. And so, Canada saw raids. Hundreds of dispensaries raided, and many people were arrested if only temporarily. Products were seized. However, these raids generally proved ineffective and we saw most of these dispensaries open the next day. While the daily amounts seized might have sounded like a lot, they were only about one day’s sales for most of these locations, providing the authorities with a better glimpse into just how much diversion of the supposedly controlled substance was going on.

Given that cannabis is promised for recreational legalization in the spring of 2017 in Canada, many are wondering about what sort of business opportunities there might be on the horizon. We know that while control of production will probably remain similar to how it is now, our distribution models will change. Here are a few points Health Canada is considering in their latest discussions:

A phased-in approach to distribution will probably be necessary. First, continuing with the mail-order system would be the easiest phase in approach.
Regulated storefronts as an alternative to the current dispensaries. It is doubtful that dispensaries operating as they are will continue. There are rumors floating around that Shopper’s Drug Mart and other pharmacies will be able to help with distribution. Time will tell if these rumors evolve.
Provincial and Territorial uniqueness. Distribution could be altered at regional levels and different models could be developed across the country, similar to liquor regulations in effect. Some of our provincial liquor distribution entities have inquired to become distributors.
Keep cannabis away from minors. Health Canada is considering a look at locations, hours of operation, density of retailers and producers and consumption of cannabis outside of personal dwellings all as factors in the new system.
Guarding against impaired driving. Our regulators want to make sure they have enough tools to monitor those who may have been driving after consumption of cannabis.
Sound product packaging and labeling. A focus on understanding THC & CBD potencies as well as appropriate health warning messages. Packaging and Labeling, and effectively sound testing, will all be necessary.

Want to know more, or see for yourself? Check out Health Canada’s latest discussion document.

Curious to know what this will mean for packaging and labeling? Get in touch with me to better understand what Eurofins-Experchem currently tests for with our Licensed Producers. Contact me at 416 665 2134 ext 252 or teganadams@eurofins.com

May 18, 2016

Quality From Canada

Secure Software Monitoring — Two Keys to Success

By Tegan Adams

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We have two key software platforms at our laboratory that help us stay compliant with our standard operating procedures. Saif Al-Dujaili, quality manager at Eurofins-Experchem, oversees quality assurance in our laboratory. As we like to say, you are safe with Saif.

A Customized Sample Tracking System

Sample-tracking software consists of four main modules:

Tracking samples in our facility: When a sample is booked by our tracking system, a unique identification number is generated by the system and printed on a sticker, which is placed on the sample. When a sample is booked, department heads then have the ability to assign work orders to the analysts through the tracking system.

When testing is complete, results are entered by the analyst into the tracking system and reviewed by the quality assurance (QA) department. QA reviewers are responsible for approving results entered in the system before they are sent to the client. A certificate of analysis is then generated and e-mailed to the client for their review.

Controlling stability studies conducted in our facility: Stability studies are scheduled and controlled on different samples pulled for analysis. Within our facility’s sample-tracking system we have different chamber names with different conditions where products can be placed. Which chamber we place samples in depends on protocols and requests from our client. The software used also generates a unique study number for each stability study that occurs. The stability schedule that includes each study is reviewed every week by the stability coordinator to schedule what samples need to be pulled for testing.

Controlling methods used for tests: Methods are entered into the tracking system after department heads have reviewed them and it is approved by QA. The tracking system generates a unique ID number for each method as well as each sample. The method can now be tracked in our laboratory’s system. Within the software you can enter the name of the method, client name and effective date and any revisions applied to the method.

Controlling inventory of columns and electrodes: Sample tracking also helps us with our purchasing patterns to make sure we have supplies for our client’s testing needs. Every time that columns and electrodes are received, they are entered into our tracking system for inventory purposes.

REES Environmental Monitoring Software

REES is used to monitor the environmental conditions of our testing facility. Key inputs measured include temperature, humidity, differential pressure and elimination or intensity of light. REES is linked to the QA department’s computers. An audible alarm is sounded as well as e-mails sent to QA personnel to notify them if anything is out of specification. REES also phones related personnel’s cell phones to notify them of any alarms. No alarms are missed, even if they occur after working hours. Having a 24-hour environmental monitoring system in place helps Eurofins-Experchem ensure integrity in operations of stability, microbiological and other environmental conditions essential for accuracy in testing results.

April 19, 2016

Quality From Canada

Following a Cannabis Sample Through the Lab: 9 Important Steps

By Tegan Adams

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Anytime a cannabis sample enters a laboratory, the sample is received, handled, weighed, identified and traced throughout the testing and disposal process. Laboratories working with cannabis must have quality systems in place to ensure every action taken to test the cannabis sample is documented and in compliance with good manufacturing practices. Eurofins-Experchem’s sample receipt and handling SOPs includes the following key elements.

Purpose: The purpose of the SOP is outlined to make sure it’s outcome is understood
Scope: The Scope of the SOP explains what events the SOP is intended to avoid and which events the SOP is intended to encourage
Responsibilities: All positions that the SOP affects are outlined
Initial Receipt of the Sample: Samples are submitted to Eurofins Experchem Laboratories with a Sample Information Form. In Canada, cannabis is regulated as a controlled substance. Controlled substances come with a special shipping document and must be weighed upon receipt to the lab to make sure the weight is the same as the client has indicated. Cannabis samples received are inspected to ensure no tampering or damage has occurred to the sample before it is tested. Any temperature and/or storage requirements are noted and followed. If any conditions are not understood the client is contacted for clarification immediately. Pending the sample’s conditions are met, the sample is placed into the laboratory.
Procedure: Eurofins Experchem uses its own sample tracking software to track a sample across the lab. A unique project number and date of entry is given to the sample. Client name, product name, condition of sample, test(s) performed, ID or lot number and size of samples are all recorded. A sticker is attached to the sample to clarify.
Rush Samples: Rush samples are stamped “RUSH” in red and are placed in a priority sequence. The sample is placed in the safe until required for testing. If the product is not cannabis, the sample is placed on a shelf corresponding with the actual day of the month it was received and entered into sample tracking. If the sample requires cold temperatures it is placed in a refrigerated area and monitored in a similar way.
Discrepancies: Any discrepancies in information found on the sample that may differentiate from what the client requests will be communicated to the client upon finding.
Controlled Documents: Stickers, original lab specification sheets, sample submission forms, and SOP training evaluation questionnaires.
Results: As soon as testing is completed, lab results are approved by quality assurance reviewers. A Certificate of Analysis (COA) is electronically and automatically sent through the sample tracking system to the client’s email.

March 23, 2016

Quality From Canada

Quality Training in a GMP Testing Facility: 8 Steps to Get Employees Compliant

By Tegan Adams

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Eurofins-Experchem Laboratories is a Health Canada and FDA-accredited analytical laboratory with a regulatory support division. The laboratory carries out testing for many different sectors including pharmaceuticals, cosmetics, natural health products and medical devices. Starting in 2014, cannabis testing was incorporated into the mix. One reason our results so accurate is due to rigorous staff orientation and training method. Diligent staff training and monitoring is very important for success as a Good Manufacturing Practices (GMP) facility with a Drug Establishment Licence and Narcotics License. So what does that look like on the inside? Saif Al-Dujaili, our quality assurance manager, Sohil Mana, our vice president of operations, and I will provide some guidelines for developing training programs below.

Introductory Session: When any new employee starts an introductory phase, it begins with general admin, a facility tour, policy manual training, govt. legislation overview and health and safety training and orientation (WHIMS and Bill 168) specific to our lab. We record signatures on any pertinent forms for SOPs that the new employee will be using.
Standard Operating Procedures: Any new employee must read all related SOPs and is evaluated on their understanding of them through questionnaires/quizzes. SOPs are written for all equipment, instrumentation or process that is applied in the lab, to ensure consistency across operations.
Laws and Regulations: New employees must be familiar or familiarized with Good Manufacturing Practices and Good Laboratory Practices. Analysts are required to read all sections of the USP pertinent to their role, as decided by the quality manager and/or dept. head and a checklist is recorded on training.
Methods: Different methods are used to test products including Compendium or other published methods with organizations such as the Association of Analytical Communities (AOAC) and the American Chemical Society (ACS). Client Methods and house-developed methods are also used. If there is a change to any method, a change control form must be filled out and documented.
Documentation: Documentation is very important in a GMP lab. All data is recorded in a hard cover bound book and/or approved worksheets. Quality assurance data reviewers are responsible for ensuring all data is being recorded properly.
Sample Management: Employees are trained on sample management related to sample entry, how samples are distributed to analysts, turn-around time, and where finished projects are placed.
Training Forms: Everything an employee learns must be recorded and filed for records. Analysts must follow a training matrix on qualitative and quantitative testing methods. Recurrent training occurs each 3 years or less depending on the position the analyst holds. Any updates on GMPs, new instruments or equipment is ongoing and recorded. Experchem runs “ghost” samples through its laboratory to ensure compliance by employees at any given time. Employees are evaluated on their abilities to comply.
Ongoing Training: Once employees are up and running they also receive monthly training in the lab and an annual GMP training followed by a comprehensive quiz that must be passed for them to continue work.

Interested in learning more about cannabis testing in Canada and the US? Contact Tegan Adams, business development manager with Eurofins at teganadams@eurofins.com.

Editor’s Note: Eurofins-Experchem has helped submit over 150 MMPR applications to Health Canada and continues to work with 10 of the 27 licensed MMPR producers in Canada. Their regulatory affairs division has started working with companies applying to produce and distribute cannabis in those states, which are new to its sale and distribution. They offer services include writing SOPs, training staff and performing mock inspection audits.

February 9, 2016

Quality From Canada

The Great Green North: Canada vs. US in Cannabis Regulations

By Tegan Adams

5 Comments

A lot has been changing quickly in the world of cannabis across North America. While international drug treaties sit back and watch in horror, cannabis and cannabis-infused products have been popping up in households across Canada, on retail shelves and in private delivery services across the US. How each jurisdiction in North America accepts and regulates (or draws a blind eye) to the sale of cannabis is different depending on where you are located. Here are a few key distinctions between the current Canadian and US regulatory approaches to marijuana.

In Canada, cannabis is regulated at the federal level by Health Canada through the Marihuana for Medical Purposes Regulations, (MMPR). The MMPR allows persons to obtain dried cannabis for their own personal medical purposes or for another person for whom they are responsible. To obtain dried cannabis, a person must obtain a medical document from a physician, or nurse practitioner to register as a client with a licensed producer of their choosing. After registering as a client, they are able to order dried cannabis and possess up to a maximum of 150 grams at any one time, depending on the recommendation of their physician. More recently, in 2015, regulations allow the distribution of not only the dried form of cannabis but also their extracted forms.

In the US, at the federal level, cannabis is still 100% illegal. Public statements from the federal administration dictate that they steadfastly oppose legalization of cannabis and other drugs. They are concerned that legalization would increase the availability and use of illicit drugs, and pose significant health and safety risks to all Americans, particularly young people. At the state level, legalization laws are rapidly changing. The office of National Drug Control Policy lists 23 states (a rising number) and Washington DC that have passed laws allowing cannabis to be smoked for a variety of medical conditions. The state laws do not change federal regulation. Many local governments are creating zoning and other restrictions that prohibit dispensaries from operating in their communities. That being said, voters in Alaska, Colorado, Oregon and Washington state support legalizing the sale and distribution of cannabis to adults over 21. There are many differences in the regulation of marijuana within each state, municipality and within the country itself.

Internationally, Canada has a platinum reputation for delivering and regulating quality consumer products. Within the Canadian cannabis industry, many feel Health Canada’s regulatory regime is inaccessible, restricts production to large corporations and limits distribution channels. The average start up cost of even a small licensed facility is around $4-5M CAD. On top of the financial costs, production companies have to compete with the other 2000 or so applicants who have been waiting, in some cases up to two years, to hear back from Health Canada if they will succeed in the licencing application process. In response, Canada has seen many tolerances made to allow dispensaries to distribute marijuana at the municipal level, even though not allowed as per regulation.

Many Canadian dispensaries operate with professional policies and procedures including providing customers with access ID cards and offering physician consults. Vancouver became the first city in Canada to license and regulate marijuana dispensaries. The number of licenses within the city exceeds both Tim Hortons and Starbucks Franchises combined. Many dispensaries provide bar and café settings for people to enjoy a “bong shot” or café au lait infused with cannabis. Licensing dispensaries has become a great financial resource for the city, charging $30,000 CAD per licence. Vancouver’s dispensaries have been a topic of debate across all levels of government. The Health Minister asked Vancouver to shut the dispensaries down, while other municipalities have started to expand the same concept. The Royal Canadian Mounted Police (RCMP), Canada’s federal police force, has started raiding various dispensary locations. Part of the new Prime Minister, Justin Trudeau’s, political platform and claim to fame is to legalize cannabis recreationally across Canada. How the framework will unfold is still in the works and subject not only to local jurisdictional reform but also to international negotiations.