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The Four Pillars of Cannabis Processing

By Christian Sweeney
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Cannabis extraction has been used as a broad term for what can best be described as cannabis processing. A well-thought-out cannabis process goes far beyond just extraction, largely overlapping with cultivation on the front-end and product development on the back-end1. With this in mind, four pillars emerge as crucial capabilities for developing a cannabis process: Cultivation, Extraction, Analytics and Biochemistry.

The purpose and value of each pillar on their own is clear, but it is only when combined that each pillar can be optimized to provide their full capacities in a well-designed process. As such, it is best to define the goals of each pillar alone, and then explain how they synergize with each other.

At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.Cultivation is the foundation of any horticultural process, including cannabis production. Whether the goal be to convert pigments, flavors or bioactive compounds into a usable form, a natural process should only utilize what is provided by the raw material, in this case cannabis flower. That means cultivation offers a molecular feedstock for our process, and depending on our end goals there are many requirements we may consider. These requirements start as simply as mass yield. Various metrics that can be used here include mass yield per square foot or per light. Taken further, this yield may be expressed based not only on mass, but the cannabinoid content of the plants grown. This could give rise to a metric like CBD or THC yield per square foot and may be more representative of a successful grow. Furthermore, as scientists work to learn more about how individual cannabinoids and their combinations interact with the human body, cultivators will prioritize identifying cultivars that provide unique ratios of cannabinoids and other bioactive compounds consistently. Research into the synergistic effect of terpenes with cannabinoids suggests that terpene content should be another goal of cultivation2. Finally, and most importantly, it is crucial that cultivation provide clean and safe materials downstream. This means cannabis flower free of pesticides, microbial growth, heavy metals and other contaminants.

Extraction is best described as the conversion of target molecules in cannabis raw material to a usable form. Which molecules those are depends on the goals of your product. This ranges from an extract containing only a pure, isolated cannabinoid like CBD, to an extract containing more than 100 cannabinoids and terpenes in a predictable ratio. There are countless approaches to take in terms of equipment and process optimization in this space so it is paramount to identify which is the best fit for the end-product1. While each extraction process has unique pros and cons, the tunability of supercritical carbon dioxide provides a flexibility in extraction capabilities unlike any other method. This allows the operator to use a single extractor to create extracts that meet the needs of various product applications.

Analytics provide a feedback loop at every stage of cannabis production. Analytics may include gas chromatography methods for terpene content3 or liquid chromatography methods for cannabinoids 3, 4, 5. Analytical methods should be specific, precise and accurate. In an ideal world, they can identify the compounds and their concentrations in a cannabis product. Analytics are a pillar of their own due simply to the efforts required to ensure the quality and reliability of results provided as well as ongoing optimization of methods to provide more sensitive and useful results. That said, analytics are only truly harnessed when paired with the other three pillars.

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Figure 1: When harnessed together the pillars of cannabis processing provide platforms of research and investigation that drive the development of world class products.

Biochemistry can be split into two primary focuses. Plant biochemistry focuses back towards cultivation and enables a cannabis scientist to understand the complicated pathways that give rise to unique ratios of bioactive molecules in the plant. Human biochemistry centers on how those bioactive molecules interact with the human endocannabinoid system, as well as how different routes of administration may affect the pharmacokinetic delivery of those active molecules.

Each of the pillars require technical expertise and resources to build, but once established they can be a source of constant innovation. Fig. 1 above shows how each of these pillars are connected. At the intersection of each pillar, specific technology platforms exist that can effectively drive an innovation and discovery cycle towards the development of ideal products.

For example, at the intersection of analytics and cultivation I can develop raw material specifications. This sorely needed quality measure could ensure consistencies in things like cannabinoid content and terpene profiles, more critically they can ensure that the raw material to be processed is free of contamination. Additionally, analytics can provide feedback as I adjust variables in my extraction process resulting in optimized methods. Without analytics I am forced to use very rudimentary methods, such as mass yield, to monitor my process. Mass alone tells me how much crude oil is extracted, but says nothing about the purity or efficiency of my extraction process. By applying plant biochemistry to my cultivation through the use of analytics I could start hunting for specific phenotypes within cultivars that provide elevated levels of specific cannabinoids like CBC or THCV. Taken further, technologies like tissue culturing could rapidly iterate this hunting process6. Certainly, one of the most compelling aspects of cannabinoid therapeutics is the ability to harness the unique polypharmacology of various cannabis cultivars where multiple bioactive compounds are acting on multiple targets7. To eschew the more traditional “silver bullet” pharmaceutical approach a firm understanding of both human and plant biochemistry tied directly to well characterized and consistently processed extracts is required. When all of these pillars are joined effectively we can fully characterize our unique cannabis raw material with targeted cannabinoid and terpene ratios, optimize an extraction process to ensure no loss of desirable bioactive compounds, compare our extracted product back to its source and ensure we are delivering a safe, consistent, “nature identical” extract to use in products with predictable efficacies.

Using these tools, we can confidently set about the task of processing safe, reliable and well characterized cannabis extracts for the development of world class products.


[1] Sweeney, C. “Goal-Oriented Extraction Processes.” Cannabis Science and Technology, vol 1, 2018, pp 54-57.

[2] Russo, E. B. “Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects.” British Journal of Pharmacology, vol. 163, no. 7, 2011, pp. 1344–1364.

[3] Giese, Matthew W., et al. “Method for the Analysis of Cannabinoids and Terpenes in Cannabis.” Journal of AOAC International, vol. 98, no. 6, 2015, pp. 1503–1522.

[4] Gul W., et al. “Determination of 11 Cannabinoids in Biomass and Extracts of Different Varieties of Cannabis Using high-Performance Liquid Chromatography.” Journal of AOAC International, vol. 98, 2015, pp. 1523-1528.

[5] Mudge, E. M., et al. “Leaner and Greener Analysis of Cannabinoids.” Analytical and Bioanalytical Chemistry, vol. 409, 2017, pp. 3153-3163.

[6] Biros, A. G., Jones, H. “Applications for Tissue Culture in Cannabis Growing: Part 1.” Cannabis Industry Journal, 13 Apr. 2017, www.cannabisindustryjournal.com/feature_article/applications-for-tissue-culture-in-cannabis-growing-part-1/.

[7] Brodie, James S., et al. “Polypharmacology Shakes Hands with Complex Aetiopathology.” Trends in Pharmacological Sciences, vol. 36, no. 12, 2015, pp. 802–821.

A More Effective and Efficient Approach to Purer Cannabidiol Production Using Centrifugal Partition Chromatography

By Lauren Pahnke
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Many physicians today treat their patients with cannabidiol (CBD, Figure 1), a cannabinoid found in cannabis. CBD is more efficacious over traditional medications, and unlike delta-9 tetrahydrocannbinol (THC), the main psychoactive compound in cannabis, CBD has no psychoactive effects. Researchers have found CBD to be an effective treatment for conditions such as cancer pain, spasticity in multiple sclerosis, and Dravet Syndrome, a form of epilepsy.

CBD is still considered an unsafe drug under federal law, but to meet the medical demand, 17 states in the US recently passed laws allowing individuals to consume CBD for medical purposes. A recent survey found that half of medicinal CBD users rely on the substance by itself for treatment. As doctors start using CBD to treat more patients, the demand for CBD is only expected to rise, and meeting that demand can pose challenges for manufacturers who are not used to producing such high quantities of CBD. Furthermore, as CBD-based drugs become more popular, the US Food and Drug Administration (FDA) will likely require manufacturers to demonstrate they can produce pure, high-quality products.

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Figure 1. The structure of cannabidiol, one of 400 active compounds found in cannabis.

Most manufacturers use chromatography techniques such as high performance liquid chromatography (HPLC) or flash chromatography to isolate compounds from natural product extracts. While these methods are effective for other applications, they are not, however, ideal for CBD isolate production. Crude cannabis oil contains some 400 potentially active compounds and requires pre-treatment prior to traditional chromatography purification. Both HPLC and flash chromatography also require silica resin, an expensive consumable that must be replaced once it is contaminated due to irreversible absorption of compounds from the cannabis extract. All of these factors limit the production capacity for CBD manufacturers.

Additionally, these chromatography methods use large quantities of solvents to elute natural compounds, which negatively impacts the environment.

A Superior Chromatography Method

Centrifugal partition chromatography (CPC) is an alternative chromatography method that can help commercial CBD manufacturers produce greater quantities of pure CBD more quickly and cleanly, using fewer materials and generating less toxic waste. CPC is a highly scalable CBD production process that is environmentally and economically sustainable.

The mechanics of a CPC run are analogous to the mechanics of a standard elution using a traditional chromatography column. While HPLC, for instance, involves eluting cannabis oil through a resin-packed chromatography column, CPC instead elutes the oil through a series of cells embedded into a stack of rotating disks. These cells contain a liquid stationary phase composed of a commonly used fluid such as water, methanol, or heptane, which is held in place by a centrifugal force. A liquid mobile phase migrates from cell to cell as the stacked disks spin. Compounds with greater affinity to the mobile phase are not retained by the stationary phase and pass through the column faster, whereas compounds with a greater affinity to the stationary phase are retained and pass through the column slower, thereby distributing themselves in separate cells (Figure 2).

Figure 2- CPC
Figure 2. How CPC isolates compounds from complex, natural mixtures. As the column spins, the mobile phase (yellow) moves through each cell in series. The compounds in the mobile phase (A, B, and C) diffuse into the stationary phase (blue) at different rates according to their relative affinities for the two phases.

A chemist can choose a biphasic solvent system that will optimize the separation of a target compound such as CBD to extract relatively pure CBD from a cannabis extract in one step. In one small-scale study, researchers injected five grams of crude cannabis oil low in CBD content into a CPC system and obtained 205 milligrams of over 95% pure CBD in 10 minutes.

Using a liquid stationary phase instead of silica imbues CPC with several time and cost benefits. Because natural products such as raw cannabis extract adhere to silica, traditional chromatography columns must be replaced every few weeks. On the other hand, a chemist can simply rinse out the columns in CPC and reuse them. Also, unlike silica columns, liquid solvents such as heptane used in CPC methods can be distilled with a rotary evaporator and recycled, reducing costs.

Environmental Advantages of CPC

The solvents used in chromatography, such as methanol and acetonitrile, are toxic to both humans and the environment. Many environmentally-conscious companies have attempted to replace these toxic solvents with greener alternatives, but these may come with drawbacks. The standard, toxic solvents are so common because they are integral for optimizing purity. Replacing a solvent with an alternative could, therefore, diminish purity and yield. Consequently, a chemist may need to perform additional steps to achieve the same quality and quantity achievable with a toxic solvent. This produces more waste, offsetting the original intent of using the green solvent.

CPC uses the same solvents as traditional chromatography, but it uses them in smaller quantities. Furthermore, as previously mentioned, these solvents can be reused. Hence, the method is effective, more environmentally-friendly, andeconomically feasible.

CPC’s Value in CBD Production

As manufacturers seek to produce larger quantities of pure CBD to meet the demand of patients and physicians, they will need to integrate CPC into their purification workflows. Since CPC produces a relativelyduct on a larger scale, it is equipped to handle the high-volume needs of a large manufacturer. Additionally, because it extracts more CBD from a given volume of raw cannabis extract, and does not use costly silica or require multiple replacement columns, CPC also makes the process of industrial-scale CBD production economically sustainable. Since it also uses significantly less solvent than traditional chromatography, CPC makes it financially feasible to make the process of producing CBD more environmentally-friendly.

Suggested Reading:

CPC 250: Purification of Cannabidiol from Cannabis sativa

Introduction to Centrifugal Partition Chromatography

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Colorado Debuts Universal THC Symbol

By Aaron G. Biros
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Yesterday, the Colorado Marijuana Enforcement Division issued a bulletin unveiling their universal symbol for all cannabis products. According to the bulletin, the State Licensing Authority adopts the universal symbol for all packaging, labeling and on-product marking for medical and recreational cannabis products, effective immediately.

UniversalSymbolCOMED“The State Licensing Authority’s adoption of a Single Universal Symbol is intended to further protect public health and safety by enhancing consumers’ ability to identify products containing marijuana,” reads the bulletin, signed by James Burack, director of the Marijuana Enforcement Division. “Further, by eliminating distinctions between Universal Symbols for medical and retail marijuana, the Single Universal Symbol works to simplify and improve compliance regarding packaging, labeling, and product marking requirements.”

On January 1st, 2019, use of the universal symbol on packaging will be mandatory for all products, with a few exceptions for medical center sales with existing inventory. There is an optional use period that lasts until the end of 2018 where producers and retailers can use the previous universal symbols. After July 1st, 2019, every product sold in the state of Colorado must have the updated universal symbols, according to the bulletin.UniversalSymbolCOMED2

On packaging and labeling, the red and white symbol is required whereas on single servings, the symbol must be on one side but doesn’t need to have the colors.

Back in 2016, Colorado began using a THC universal symbol, requiring it on infused product servings, essentially as a warning symbol on edibles. With this newly implemented rule, all products, including packaging for flower and concentrates, must have the symbol on it. Licensees are encouraged to visit the MED’s website for more information.

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FDA Issues Warning To CBD Companies

By Aaron G. Biros
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On November 1st, the U.S. Food and Drug Administration (FDA) published a press release addressing warning letters issued to four companies. The warning letters, sent to companies marketing cannabidiol (CBD) products with therapeutic claims, cites unsubstantiated claims about their products’ ability to treat or cure cancer and other diseases.

A snippet of the warning letter issued to Greenroads

According to the press release, the four companies that received warning letters are Greenroads Health, Natural Alchemist, That’s Natural! Marketing and Consulting, and Stanley Brothers Social Enterprises LLC. The press release called their marketing campaigns “deceptive” for “unproven treatments.” Here is the letter they sent to Greenroads Health.

“As part of the U.S. Food and Drug Administration’s ongoing efforts to protect consumers from health fraud, the agency today issued warning letters to four companies illegally selling products online that claim to prevent, diagnose, treat, or cure cancer without evidence to support these outcomes,” reads the FDA statement. “Selling these unapproved products with unsubstantiated therapeutic claims is not only a violation of the Federal Food, Drug and Cosmetic Act, but also can put patients at risk as these products have not been proven to be safe or effective.”

According to the press release, the FDA has issued ninety warning letters in the past ten years, with around twelve this year, to companies making fraudulent claims about cancer therapies. Here are some examples of claims made by companies that the FDA took issue with:

  • “Combats tumor and cancer cells;”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells;”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors,” says FDA Commissioner Scott Gottlieb, M.D. “We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products. There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

 

Canadian Company Recalls Contaminated Cannabis

By Aaron G. Biros
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Broken Coast Cannabis Ltd., a cannabis business located on Vancouver Island, issued a voluntary recall of three cannabis lots due to the detection of pesticides. According to the safety alert published on Health Canada’s website, the voluntary Type III recall follows an inspection of the facility back in March of this year.

A Type III recall means those products are not likely to cause negative health effects. Sampling of those three cannabis lots found a cannabis oil product in July to contain low levels of Myclobutanil and Spinosad.

Upon further testing, a cannabis leaf sample was found to contain 0.017 parts-per-million of Myclobutanil. A third party laboratory confirmed the presence of that fungicide, leading them to recall three lots of dried cannabis sold between July and December of 2016, according to that safety alert.

Spinosad, an insecticide, and Myclobutanil, a fungicide, are not authorized for use with cannabis plants per the Pest Control Products Act, however they are approved for use in food production. The health risks of ingesting either of those two chemicals are well documented. “Health Canada has not received adverse reaction reports related to Broken Coast Cannabis Ltd.’s products sold affected by the recall,” reads the safety alert. “Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and to contact Broken Coast Cannabis Ltd., at the following number 1-888-486-7579.”

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Clear vs. Pure: How Fallacies and Ignorance of Extraction Misrepresent the Cannabis Flower

By Dr. Markus Roggen
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Demand for cannabis extracts, in particular vaping products, is at an all-time high. People want good oil, and they want to know something about the quality of it. It is therefore time to take a step back and consider the process from plant to cartridge. What is the current industry standard for cannabis extraction, what constitutes quality and where might we need to make some adjustments?

Right now, “clear” oil is hot. Customers have been led to believe that a pale gold extract is synonymous with the best possible cannabis concentrate, which is not necessarily the case. Producing a 95% pure THC extract with a translucent appearance is neither a great scientific feat nor a good representation of the whole cannabis flower. Moreover, it runs counter to the current trend of all-natural, non-processed foods and wellness products.

“My carrots are organic and fresh from the farmers market, my drink has no artificial sweeteners and my honey is raw, but my cannabis oil has undergone a dozen steps to look clear and still contains butane.”Cannabis is a fascinating plant. It is the basis of our livelihood, but more importantly, it enhances the quality of life for patients. The cannabis plant offers a plethora of medicinally interesting compounds. THC, CBD and terpenes are the most popular, but there are so many more. As of the most recent count, there are 146 known cannabinoids1. Cannabinoids are a group of structurally similar molecules2, including THC and CBD, many of which have shown biological activity3.

Then there are terpenes. These are the smaller molecules that give cannabis its distinct smell and flavor, over 200 of which have been identified in cannabis4. But wait, there’s more. The cannabis plant also produces countless other metabolites: flavonoids, alkaloids, phenols and amides5. All these components mixed together give the often-cited entourage effect6,7.

Current industry standards for cannabis oil extraction and purification stand in marked contrast to the complexity of the plant’s components. Due to an unsophisticated understanding of the extraction process and its underlying chemistry, cannabis oil manufacturers frequently produce oil of low quality with high levels of contamination. This necessitates further purifications and clean up steps that remove such contaminants unfortunately along with beneficial minor plant compounds. If one purifies an extract to a clear THC oil, one cannot also offer the full spectrum of cannabinoids, terpenes and other components. Additionally, claiming purities around 95% THC and being proud of it, makes any self-respecting organic chemist cringe8.

Precise control of extraction conditions leads to variable, customized concentrates. THC-A crumble, terpene-rich vape oil, THC sap (from left to right).

The labor-intensive, multi-step extraction process is also contrary to “the clean-label food trend”, which “has gone fully mainstream”9. Exposing the cannabis flower and oil to at least half a dozen processing steps violates consumer’s desire for clean medicine. Furthermore, the current practice of calling supercritical-CO2-extracted oils solvent-less violates basic scientific principles. Firstly, CO2 is used as a solvent, and secondly, if ethanol is used to winterize10, this would introduce another solvent to the cannabis oil.

We should reconsider our current extraction practices. We can offer cannabis extracts that are free of harmful solvents and pesticides, give a better, if not full, representation of the cannabis plant and meet the patients’ desire for clean medicine. Realizing extracts as the growth-driver they are11 will make us use better, fresher starting materials12. Understanding the underlying science and learning about the extraction processes will allow us to fine-tune the process to the point that we target extract customized cannabis concentrates13. Those, in turn, will not require additional multi-step purification processes, that destroys the basis of the entourage effect.

The cannabis industry needs to invest and educate. Better extracts are the result of knowledgeable, skilled people using precise instruments. Backroom extraction with a PVC pipe and a lighter should be horror stories of the past. And only when the patient knows how their medicine is made can they make educated choices. Through knowledge, patients will understand why quality has its price.

In short, over-processing to make clear oil violates both the plant’s complexity and consumers’ desires. Let us strive for pure extracts, not clear. Our patients deserve it.


[1] Prof. Meiri; lecture at MedCann 2017

[2] ElSohly, Slade, Life Sciences 2005, 539

[3] Whiting, et. al., JAMA. 2015, 2456

[4] Andre, Hausman, Guerriero, Frontiers in Plant Science 2016, 19

[5] Hazekamp, et. al., Chemistry of Cannabis Chapter 3.24; 2010 Elsevier Ltd.

[6] Ben-Shabat, et al.; Eur J Pharmacol. 1998, 23

[7] Mechoulam, et al.; Nat Prod Rep. 1999, 131

[8] Medical and Research Grade chemicals are generally of purities exceeding 99.9%

[9] Bomgardner, Chemical & Engineering News 2017, 20

[10] Winterization is the industry term for what is correctly referred to as precipitation.

[11] Year-over changes to market shares in Colorado 2015 to 2016: Concentrates 15% to 23%; Flower 65% to 57%, BDS Analytics, Marijuana Market Executive Report, 2017

[12] Further reading about the whole extraction process: B. Grauerholz, M. Roggen; Terpene and Testing Magazine, July/Aug. 2017

[13] Further reading about optimizing CO2 extraction: M. Roggen; Terpene and Testing Magazine, May/June 2017, 35

Florida Medical Cannabis Market Growth Stymied By Red Tape

By Aaron G. Biros
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The demand for medical cannabis in Florida might be growing steadily, with patient numbers soaring, but that doesn’t mean the market will grow accordingly. Due to hampering regulations and a lack of state guidance, the industry in Florida is tiny and patients have limited options for medical cannabis products.

A little more than three years ago, Governor Rick Scott signed a bill into law, legalizing medical cannabis, but only for terminally ill patients and only for one strain, Charlotte’s Web. That stipulated a low-THC, concentrated oil form of cannabis. That bill also set up the licensing framework for what is now an extremely limited market.

Florida Gov. Rick Scott has been accused of making the licensing process secretive Photo: Gage Skidmore, Flickr

In November of 2015, the Office of Compassionate Use, now called the Office of Medical Marijuana, issued licenses for five dispensaries. To get a license, applicants needed to meet a variety of absurd requirements. That included being a nursery in business for thirty years, growing a minimum of 400,000 plants at the time of applying, paying $300,000 in fees and a $5 million performance bond.

Fast forward to Election Day last year when voters passed Amendment 2 by a wide margin, amending the state’s constitution and legalizing medical cannabis for a broader scope of qualifying conditions. What hasn’t changed, however, is the old vertical licensing framework. Critics have dubbed this a “pay-to-play” market, with massive barriers to entry prohibiting small businesses from gaining market access.

David C. Kotler, Esq.

David Kotler, Esq., attorney and partner at CohenKotler P.A., says we shouldn’t expect to see a viable market for years as a result of all this red tape. “Honestly the State of Florida, with their limited licenses and odd requirements to qualify for licensure have stunted what could be a good market both for businesses and patients,” says Kotler. “It has been an inefficient roll-out and is truly an embarrassment for the state, legislature and the Department of Health.” Kotler says he’s heard reports of extremely limited product selection, poor quality, as well as no dried flower being offered.

But the patients are pouring in by the thousands- on July 27th, the Office of Medical Marijuana reported 26,968 registered medical patients, with more than 10,000 patients signing up since June 7th. “Despite my belief that it would be a slow roll out, it appears the patient count is picking up,” says Kotler. “The elimination of the 90-day doctor-patient relationship will certainly help this.” He is referring to the reversal of a waiting period policy, where patients had to wait 90 days before receiving a medical cannabis certification. “But there still seems to be a backup with issuance of cards and poor guidance from the Department of Health leaving many doctors unsure of what they should be doing,” says Kotler. The rules and guidelines for physicians participating in the program are still not established, but the Florida Board of Medicine expects to vote on them this week, reports say.

Matt Karnes, founder and managing partner of GreenWave Advisors

With seven licensees right now and a total of ten licensees by October allowed to grow and distribute cannabis products, the question remains if that is enough to satisfy the growing number of patients. According to Matt Karnes, founder and managing partner of GreenWave Advisors, the state is adjusting by adding more licensees and allowing them to operate more dispensaries, potentially trying to sate that demand. “Both of these amendments will likely serve as a catalyst for revenue growth but could be tempered by a lack of physician participation (as we have seen in other states) in the medical marijuana program,” says Karnes. “For every incremental 100,000 patients who register in the Medical Marijuana program, four more licenses will be issued and existing licensees will be allowed to open another four dispensaries (current cap is 25). We do not expect an incremental 100,000 patients until sometime in 2021.” His firm’s market projections account for those increases and edibles now being sold, but still no dry flower allowed. They project total sales figures in the state to reach $712 million by 2021.

Those figures are contingent on the increase in registered patients and more licensees. If Florida’s vertical licensing model remains, it’s quite possible the state will see a cannabis shortage, much like Nevada during their opening month of adult use sales. “Instead of learning from so many states before it, Florida forged a path down the rabbit hole that may limit Florida’s potential until either a legislative change or a backlash at the polls in the form of an amendment bringing forth adult use,” says Kotler. In New York, that vertical licensing model arguably created a monopoly, with only a select few businesses controlling the entire market. That doesn’t foster market growth; it hurts quality, keeps prices high and prevents real competition. “We see how that worked out for New York,” says Kotler. “We cling to that despite what could be a large patient base with the potential to service tourists who wish to have reciprocity.”

Florida’s market could be a powerhouse for the state, with the potential to generate millions in tax revenue, create thousands of jobs and actually help patients get the medicine they need. But until the state ditches their conservative, closed-door approach, we won’t see the industry truly flourish. .

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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 24th. 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.health-canada-logo

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.

Hemp-Derived CBD Oil: Maintaining Quality in the Manufacturing Process

By Aaron G. Biros
3 Comments

Hemp-derived cannabidiol (CBD) products are quickly becoming a burgeoning industry. Consumers can purchase the products in all fifty states and can receive the therapeutic effects of certain cannabinoids without any psychoactivity. Commonly used to help treat inflammation, pain, seizures and anxiety, CBD comprises a sizable portion of the cannabis market that patients and consumers are flocking to.

Founded by Paul Benhaim in 2013, Colorado-based Elixinol is reaching this market with a line of hemp-derived CBD oils and capsules. The company has grown rapidly and now has agreements with exclusive distributors in Japan, Puerto Rico, The United Kingdom and South Africa.

Paul Benhaim founded Elixinol in 2013
Paul Benhaim founded Elixinol in 2013

According to Chris Husong, sales and marketing director at Elixinol, achieving superior quality is central to the company’s growth strategy. “We are thinking about the long-term play here,” says Husong. Achieving the highest quality possible starts with sourcing from industrial hemp farms in Northern Europe, according to Husong. Through good manufacturing practices (GMPs), the company pays close attention to every detail involved in producing the hemp-derived CBD oil.

Safety and transparency are two core tenants in the company’s goal to strive for quality products. “We use third-party independent labs for our testing including one in Northern Europe where we source from in addition to Proverde Labs when it reaches us in Colorado,” says Husong. They test their products for over 300 chemicals (including pesticides, residual solvents and heavy metals) as well as for microbiological contamination and a unique terpene profile using GC-MS/GC-FID.

Co-founder Paul Benhaim at their extraction and testing facility in Europe.
Co-founder Paul Benhaim at their extraction and testing facility in Europe.

In addition to stringent manufacturing safety procedures and testing, tracking is a huge part of meeting quality standards. Each product batch also has a lot number. While batch numbers are a requirement in GMPs, lot numbers mean that they are well equipped in the event of a product recall. After the product is packaged, they perform additional spot-checks periodically.

Contract manufacturing and white-labeling products is a large part of their business, so the company needs to meet rigorous quality standards for their partners as well. “We provide our oil to a variety of associates, but we are always looking for new partners on the cutting edge, innovating with new products that we can help with,” says Husong. Very often, this means doing a full plant extraction for different uses. Utilizing a full-spectrum plant extraction helps maintain a well-balanced cannabinoid profile with many of the original terpenes found in the plant.

Japan's first lady, Akie Abe, purchasing Elixinol's hemp-derived CBD oil.
Akie Abe, first lady of Japan, purchasing Elixinol’s hemp-derived CBD oil.

What makes their product so appealing to consumers is not just the quality, but also the method of delivery into the bloodstream and very precise dosing. “Our liposome products have a relatively new technology that allows the oil to be absorbed into your system via fatty acids, which lets you absorb the compounds much faster, requiring less of it and more consistency,” adds Husong. In addition to their fast-acting delivery mechanism, they produce capsules dosed to precisely fifteen milligrams and a delivery system they call ‘Xpen,’ which draws the oil in an oral applicator to a precise dose of fifteen milligrams every time.

After the manufacturing process, the company pays close attention to detail in their packaging and distribution. “The packaging is built to maintain that quality in the manufacturing process and to extend the shelf life of our products,” says Husong. The technology that goes into their packaging involves using Miron Violet glass, which is anti-fungal and prevents external light from deteriorating the oil inside.

This growing sector in the cannabis market is representative of a greater trend: the commodification of hemp and cannabis. When businesses like Elixinol scale up production of goods such as CBD oil, a lens focused on consistency and quality can not only improve business operations but also raise the standard across the entire industry.

derekpeterson

Terra Tech Expands, Maintains Quality: A Q&A with CEO Derek Peterson

By Aaron G. Biros
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derekpeterson
derekpeterson
Derek Peterson, chief executive officer of Terra Tech

Terra Tech, with the recent acquisition of Blum, a dispensary in Oakland, and the line of concentrates, IVXX, is sweeping the cannabis industry by setting standards for safety and quality. Terra Tech, publicly traded in the Over-The-Counter market, is well known as an agricultural company, with the subsidiary brand, Edible Garden, selling produce to Whole Foods, Wal-Mart and Kroger’s. In December of last year, we covered Terra Tech’s entrance into the cannabis marketplace and their experience with large-scale, sustainable agriculture. We sit down with Derek Peterson, chief executive officer of Terra Tech, to get an update on their progress and quality controls.

CannabisIndustryJournal: In January, Terra Tech announced revenue guidance of $20-22 million for 2016. Can you share some of your strategy going forward to meet your goals?

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Terra Tech is taking organic and GFSI-certified agricultural practices to growing cannabis

Derek Peterson: We have always played both a long game as well as a short game, meaning while we are building our longer term business, like in Nevada, we are also focusing on short term accretive acquisitions, like we did with Blum in Oakland. We want to make sure we capture short-term revenue growth while we plan our future revenue production. We feel confident about achieving those results.

CIJ: How big of a role does the acquisition of Blum and IVXX brand expansion play in meeting those goals?

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The Oakland location of Blum dispensary

Derek: Blum is a significant factor even though we are only capturing three quarters of revenue considering we closed the deal on March 31st of this year. So for the full year of 2017 we will have growth from this level considering we will be able to report a full year of Blum revenue. IVXX presents us with the best opportunity for growth in the coming years. As the market in California and Nevada grows we can continue to expand our IVXX footprint throughout the state. Being able to wholesale to thousands of other retail facilities affords us a significant opportunity to grow our sales.

CIJ: How do you think the brand of Edible Garden positions you well for expansion in the cannabis industry? 

Poinsettias ready for distribution at Edible Garden facility in Belvidere, New Jersey
Produce ready for distribution at Edible Garden facility in Belvidere, New Jersey

Derek: One of the reasons we were so successful in the Nevada market was because regulators and legislators felt a high degree of confidence in our abilities considering we are USDA organic, Kosher and GFSI-certified. Our traditional agricultural experience has been very synergistic with our cannabis division from both an optics and operational perspective.

CIJ: Could you give us an update on progress in Medifarm LLC in Nevada? And on your distribution plan for IVXX in California?

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IVXX concentrates

Derek: We are continuing to expand our IVXX line throughout the state and increasing our sales force. In addition we will continue to develop new products to distribute into our existing supply chain, like we just did with our new pre filled cartridge line.

We are opening our Decatur location in Las Vegas in early July and Reno and Desert Inn towards the end of August. Our cultivation and extraction facilities should be complete no later than January 2017. We will have our entire infrastructure in place if the recreational bill passes in Nevada this November.

Blum Las Vegas location will open in July
Blum Las Vegas location will open in July

CIJ: Tell us about the role of laboratory testing in your business.

Derek: Laboratories play a significant role, as they are becoming a mandated step in most new legislation around the company. Independent lab testing is extremely important to maintain safe access for consumers and patients. We work primarily with Steep Hill Labs and CW analytics.

CIJ: Can you expand on your integrated pest management and your growing practices?

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Platinum Cookies ready for packaging and labelling

Derek: Well we cannot say organic, however we do cultivate all naturally. We also cultivate traditional produce that we sell to major retailers. We are USDA organic-certified and we implement similar processes in our cannabis cultivation. Pest control is extremely challenging for any farmer but we rely primarily on bio control, meaning the good bugs eat the bad bugs. This has been very effective for us in the cultivation of all our products.

CIJ: How is your business different from the slew of other dispensaries and growers in California?

Consistency in quality standards requires meticulous SOPs
Consistency in quality standards requires meticulous SOPs

Derek: Service and consistency; we have over 42,000 registered patients and our operations team has over 19 years of experience in California. One of the reasons we have become one of the largest dispensaries in the state is because of that experience. In addition, consistency is extremely important. Consumers expect the same product in every other business and ours is no different. If they come in for our Platinum Cookies one month and the next month it has different characteristics you are going to lose patient confidence. So in the front of the house, we are focused on pairing patients’ needs with the correct product and in the back of the house we are focused on providing a meticulously cultivated product, produced at the highest standards.

CIJ: Can you delve into some of the processing for concentrates? How do you meet such rigorous quality standards?

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Extraction equipment in one of the processing facilities for IVXX

Derek: Through research and development, we have engineered a proprietary process in which our solvent profiles used under our proprietary conditions ensures solvent residual levels which are not detected by instrumentation at 3rd party testing agencies such as Steep Hill Labs. In addition, any good scientific method requires repetition and corroboration of results. In order to accomplish this we also rely on random routine testing in which we send out extracts out to other 3rd party testing labs. Proprietary conditions include, but are not limited to, heat, vacuum, agitation, etc. By utilizing the correct amalgamation of solvent profiles, extraction conditions, purging conditions, as well as rigorous quality control standards, we are able to ensure a product that is void of any residual solvents, without sacrificing potency or identity of the cannabinoids and terpenes. Cannabinoids and terpenes are of chief interest when extracting cannabis for patients so that they have access to these essential oils without any of the actual leaf and bud.

All solvents used are the highest grade available to us, which ensures a truly medical product for the patient. In addition, all of our extraction equipment is routinely cleaned and sterilized using medical grade cleaning agents.