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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. .

National Hemp Association Board Chairman Meets With USDA Senior Officials

By Aaron G. Biros
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According to a press release yesterday sent out by the National Hemp Association (NHA), on Wednesday, June 28th, Board Chairman Geoff Whaling met with senior U.S. Department of Agriculture staff, along with Erica McBride from the Pennsylvania Industrial Hemp Council. The press release says this is the first time that Agricultural Secretary Perdue has had his staff meet with the hemp industry. “The meeting reaffirmed critical elements of the working relationship that the hemp industry has established with the USDA since the enactment of Sec. 7606 of the 2014 Farm Bill,” reads the press release put out by the NHA.

The press release says the USDA will support hemp pilot projects, considering grant and loan applications and other means of funding under the USDA and NIFA. “All hemp industry participants are encouraged to participate in these funding opportunities,” says Whaling. “USDA confirmed that nine Industrial Hemp funding requests to NIFA are being processed and that USDA has encouraged those who submitted previous requests to resubmit them.”

“USDA also offered to provide a quick response to any Secretary or Commissioner of Agriculture who is looking for clarification on either the Farm Bill or SOP, which may be preventing the States that have enacted enabling Industrial Hemp legislation from advancing research,” says Whaling.

A big driver of the meeting was the support of the Industrial Hemp Farming Act of 2018 on behalf of the NHA. That bill, which Congressman James Comer (R-KY) plans on introducing in July, would essentially remove hemp from the Controlled Substances Act, allowing industrial cultivation of the plant. It also would set a THC limit and give states the power to regulate their own hemp industries.

“There is new leadership in the USDA, on the Hill and within our industry,” said Whaling. “I am confident that this group will advance our industry to a level never before achieved.”

European Cannabis News Roundup- Summer 2017

By Marguerite Arnold
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Obstacles to American cannabis reform are creating a quirky if valuable market. Cannabis is still a “Schedule I” drug. From a practical perspective, this has created a multi-billion dollar industry that as of yet, cannot get reliable banking services. It also means that patients cannot get the drug covered under health insurance. There are no national safety requirements for growing, packaging, labelling or consumption.

This is certainly not the case elsewhere. Other countries are rapidly outpacing the U.S. in such regards even if their commercial markets are not (yet) of the same size. Outside of Canada right now, Europe is the place where most of these things are happening.

Just as in the U.S., however, there is no one single path to reform.

Who Is Interesting In Europe?

This is an evolving question, but here, for the moment are the market leaders and what is going on locally:

Germany. Cannareform auf Deutsch currently underway makes this the most exciting country in Europe right now. The country is basically the “California of the EU” as it were, with about 20 million more people.

German Parliament Building
Photo: NH53

As of January 19, the lower house of the German parliament voted unanimously to legalize cannabis for medical use. Further, they voted to cover it under public health insurance which covers 90% of Germans. Yes, this is a system in process. Yes, there are problems. Health insurance companies appear to have launched a tepid attempt to slow this down, but just as in Canada, they are already facing court challenges. It is a losing battle here. Both legal and legislative mandate are very clear.

This is an industry that will also begin to grow, per government estimates, at between 5-10,000 patients per year for the next couple of years. It could grow faster than that. With over 1 million potential patients already, and a high interest in plant-based and natural medicine, this is a market more than ready for cannabis products. There are now up to ten growing bids up for grabs here and those who have applied are waiting anxiously as the government is set to announce the winners this summer. The big push right now on the ground is doctor and patient education as well as getting patients signed up for trials.

Recreational reform is also far from dead here. The medical question, in fact, has only inspired activists to redouble their efforts to get recreational reform finalized sooner than later. Especially given developments elsewhere, including locally.

Bern, the capital of Switzerland
Photo: martin_vmorris

Switzerland. The Swiss are approaching the question of legalization in another unique way not seen anywhere else. That said, they are clearly inspired by events in other places. Since 2011, low-THC cannabis has been for sale in regular shops. However in the last quarter of 2016 and into the first of this year, the market all of a sudden seems to have woken up. There are now over 160 shops either selling the drug or applying to sell it. This is all product that is taxable.

Thanks to this, reformers are now pushing a bill federally that would legalize and tax the sales of all THC products – no matter their concentration. In effect, in other words, the Swiss are looking at tax revenue first. If they succeed, they will be the first country to enter the market this way. It will also push other countries, starting with their closest neighbours, to examine the question of legalization just on this front. The economic justification alone is compelling. Expect Austria to also look at the problem this way.

Spain. The country is widely billed as the “next Holland.” Why? Cannabis reform has been very similar procedurally. Due to loopholes in the current law, the Spanish have been able to establish a thriving “cannabis club” market. These clubs are member-driven and non-profit. However locals who are over the age of 21 can sign up and smoke in “semi-private.” Legislation now pending in the Spanish legislature would focus on better regulation of both the clubs and the existing grows that support them. The way the Spanish seem to be approaching the issue is to give larger cities and regions direct control over regulation of the industry. However for now, this is a market that is steadfastly resistant to commercial development on the scale seen in other places. Investors – especially from overseas, are avoiding the market because of this uncertainty.

De Wallen (Red Light District) in Amsterdam, where a number of cannabis shops are.
Photo: Bert Kaufmann

Holland. Generation X reformers are used to the idea of the grey market created by the unique nature of Dutch culture and the plant. For the better part of 40 years, the entire industry here has been based on a unique market of seed producers and growers. That, in turn, supports the coffee shop culture. There are many proposals to change the law here, and the industry will probably begin to better regulate – starting with cultivation, as the rest of Europe turns its attention to this issue. It was Holland after all, that started this. What is next for Holland 2.0? It is likely that regional developments will also shape this market too. It is still part of the EU.

Italy. While a bit of an outlier, the Italians are also in the game now. How further reform will proceed here, however is anyone’s guess. The Italian military began growing and distributing cannabis to pharmacies last year. The first medically focused canna café has now opened in Rome.

The Eastern Bloc

Eastern European countries are all over the map on legalization – although most are approaching this as a medical issue. In Czech Republic, legalization has moved forward here steadily in large part because of existing national drug policy. Croatia began importing from Canada last year in the form of cannabis concentrates. Both of those countries have digital prescription systems to integrate with medical cannabis, as part of the legislation legalizing medical use in 2015. This digital dispensation system is also unique so far in Europe, although other countries will be entering this area quickly. Even Turkey has begun to implement reform, allowing producers to begin to grow the plant domestically for local medical use.

Protecting Your Innovative Cannabis Strains With a Strong Intellectual Property Strategy: Part 2 – Patents for New Cannabis Strains

By Dr. Travis Bliss
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In the first installment of this three-part series we explored the reasons why cannabis breeders should adopt a strong IP strategy sooner rather than later and looked briefly at the types of IP that those breeders and growers should be considering. In this second installment, we will examine in more detail patent protection for innovative new varieties of cannabis and how one can use that patent protection to further their business objectives.

What is a patent and what do I do with one?

A patent is a right granted by the government to protect a new and useful invention. Importantly, a patent gives its owner an exclusionary right as opposed to a right to do something – the patent owner has the right to exclude others from making, using, selling, offering to sell, or importing the invention (or, for a plant, any of its plant parts) for the term of the patent, which is 20 years for the types of patents that can be used to protect new cannabis varieties.

Because it is an exclusionary right, there are essentially two things that a patent owner can use a patent to do: 1) disallow anyone else from producing and selling that variety (or any of its parts) so that the patent owner is able to capture all of the sales for that variety, or 2) use license contracts to allow other growers to grow the variety while paying royalties back to the patent holder. The latter option can often be beneficial because it can greatly expand production of the variety by licensing to multiple growers. However, this does require some oversight on the part of the patent holder to make sure that the product those growers are producing is high quality –growers who produce poor quality product can hurt the existing brand. Cannabis breeders should consider these options up front when formulating their IP strategy.

Which type of patent should I use to protect my new variety?

As a further consideration, there are two different types of patents that can be used to protect new plant varieties and there are multiple factors to consider when determining which one to pursue.

U.S. Plant Patents are a special type of intellectual property that is used solely for the protection of asexually/vegetatively reproduced plant varieties. Traditionally, plant patents have been used to protect new varieties of ornamental and fruit trees and shrubs, such as a new variety of rose bush or a new variety of apple tree, such as the ‘Honeycrisp’ apple tree, patented in 1990. This type of patent has recently been used to protect a new cannabis variety called ‘Ecuadorian sativa’, while several other cannabis varieties, ‘Midnight’, ‘Erez’, and ‘Avidekel’ varieties are awaiting plant patent approval.

On the other hand, a “utility patent” can be used for new “compositions” (e.g., a new type of grow light) or new types of “methods” (e.g., a new method of extracting compounds from cannabis or a new method of growing cannabis to produce higher THC content). This type of patent can also be used to protect a new plant variety so long as the applicant can demonstrate that the variety is novel and not obvious over what was already known in the art. To date, two utility patents have been issued to protect cannabis varieties that exhibit certain cannabinoid and terpene profiles (U.S. Patent Nos. 9,095,554 and 9,370,164), and other similar utility patent applications are also pending (e.g., U.S. Patent Pub. No. 2014/0298511).

One of the main determining factors in deciding which type of patent to pursue is the nature of the invention. Growers and breeders will likely want to seek a plant patent if they have developed a new variety of cannabis plant: 1) which was made using simple breeding techniques, 2) which can be stably reproduced in an asexual manner (such as by cuttings and cloning), and 3) which is different from its parents and certain other strains on the market, but not completely distinct from everything that already exists. On the other hand, growers and breeders may want to consider a utility patent if they have developed a new variety of cannabis plant: 1) which has unique features in comparison to everything else that exists today (such as a unique disease resistance or chemical makeup), 2) which has unique features that can be demonstrated by some sort of biological or chemical test, and 3) that can be reproduced either asexually or by seed. It is also important to keep in mind that these two routes are not mutually exclusive – one could apply for both types of patent if the variety satisfies the criteria for both.

Though there are numerous similarities between the processes for obtaining both types of patents, there are also clear differences that should be taken into consideration when making the decision about which type of patent to seek. For instance, the grant rate for plant patents is much higher, meaning there is a higher likelihood that the plant patent application will eventually be granted compared to a utility patent application. Further, plant patent applications typically move quicker through the Patent Office, frequently being granted in approximately 18 months, while utility patent applications typically take two to four years (or more) to issue.

Another factor that should be considered is cost. Because a plant patent application is much simpler to prepare and typically moves through the Patent Office more swiftly, the cost for obtaining a plant patent is generally significantly lower than for a utility patent.

Determining which type of patent to pursue requires consideration of numerous factors. However, it is important to keep in mind that, regardless of which type of patent a grower or breeder seeks, there are certain time limitations that can impact the right to obtain a patent. For example, patent protection can only be sought if the variety to be patented has not been sold, offered for sale, or otherwise made publicly available more than one year before the patent application is filed. After that time, the invention becomes part of the “public domain.” So if a breeder chooses to wait to seek patent protection for a new variety, they risk losing the ability to ever get that protection.

Clearly, growers and breeders have to weigh several options when formulating a patent strategy, including what type of patent to pursue and what to do with the patent once they obtain it. Thinking through these issues early on allows the cannabis breeder an opportunity to formulate a strategy that is most beneficial in furthering their business objectives. Additionally, regardless of the type of patent strategy used, it is often helpful to combine it with trademark and branding strategy, which allows the business to utilize a more comprehensive approach to IP for their innovative strains. The third installment of this series will focus on trademarks for cannabis products and some unique issues that facing the cannabis industry today.

Legal disclaimer: The material provided in this article is for informational purposes only and not for the purpose of providing legal advice. The opinions expressed herein are the opinions of the individual author and may not reflect the opinions of the firm or any individual attorney. The provision of this information and your receipt and/or use of it (1) is not provided in the course of and does not create or constitute an attorney-client relationship, (2) is not intended as a solicitation, (3) is not intended to convey or constitute legal advice, and (4) is not a substitute for obtaining legal advice from a qualified attorney. You should not act upon any such information without first seeking qualified professional counsel on your specific matter.

Israeli Cannabis Brand Tikun Olam Expands to US

By Aaron G. Biros
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Tikun Olam is a Jewish concept that addresses social policy, promoting acts of kindness to better society. In Hebrew, it literally means, “repair of the world.” The company by the same name, Tikun Olam Ltd, and now in the United States as T.O. Global LLC, was the first medical cannabis provider in Israel back in 2007. Working with patients, doctors and nurses in clinical trials, they developed 16 strains over the last decade that target alleviating symptoms of specific ailments.

Tel Aviv, Israel, where Tikun Olam has a dispensary

In November 2016, they launched their United States brand, Tikun, in the Delaware medical cannabis program with their partner, First State Compassion Center, a vertically integrated business of cultivation, extraction and retail in Wilmington. After the success of their pilot program, Tikun announced their expansion into the Nevada market with their licensed partner, CW Nevada LLC. Tikun is leveraging its experience with clinical trials and medical research to launch a line of cannabis products focused on health and wellness in the United States. According to Stephan Gardner, chief marketing officer at Tikun Olam, they have the largest collection of medical cannabis data in the world. “Tikun Olam started out as a non-profit, working to bring medication to patients in Israel,” says Gardner. “Opening nursing clinics gave us a tremendous amount of knowledge and data to work on the efficacy of strains developed specifically for targeting symptoms associated with certain conditions.” For example, their strain, Avidekel, was developed years ago as the first high-CBD strain ever created.

cannabis close up
The strain Avidekel being grown in Israel.

In a single-strain extraction, Avidekel has been used to successfully mitigate the symptoms associated with neurological conditions, like epilepsy in children, and they have the data to demonstrate that efficacy. “The American market needs some sort of guidance on how these cannabinoid and terpene profiles in certain strains can truly assist patients,” says Gardner. “We have been tracking and monitoring our patients with clinical and observational data in one, six month and annual follow ups, which are data we can use to guide the needs in the US.”

Their expansion strategy focuses heavily on the health benefits of their strains, not necessarily targeting the recreational market. “As a wellness brand in Nevada, we are positioned to work first and foremost in the medical market,” says Gardner. “Our wellness brand can cater to people looking for homeopathic remedies for things like inflammation issues, sleep disorders or pain relief for example,” says Gardner. “You will not see us going out there catering to the truly recreational market; the benefits of what our strains can do is marketed from a wellness perspective.” A cannabis product with high-THC percentages is not unique, says Gardner, but their approach using the entourage effect and proven delivery mechanisms is. “While higher THC might appeal to the rec market, that is not exactly how we will promote and position ourselves,” says Gardner. “We want to be a dominant force in the wellness market.”

Best practices include quality control protocols

That effort requires working within the US regulatory framework, which can be quite complicated compared to their experience in Israel. “We have to understand the Israeli market and American market are completely different due to the regulatory regimes each country has in place,” says Gardner. “We understand the efficacy of these products and want to educate customers on how they might benefit. We don’t want to make claims looking to cure anything, but we found in our data that a lot of symptoms in different ailments, like cancer, PTSD, Crohn’s disease, colitis and IBS, can be alleviated by strains we developed.” In addition to the medical research, they are bringing their intellectual property, cultivation methodologies, evidence-based scientific collaboration and best practices to their partners in the US.

So for Tikun’s expansion in the US, they want to get a medical dialogue going. “We will launch a fully accredited AMA [American Medical Association] program, educating medical practitioners, giving the doctors the understanding of the capabilities of cannabis and what our strains can do,” says Gardner. “We will also share our observational data with doctors so they can work to better guide their patients.” Right now, they are working on the education platform in their pilot program in Delaware. “We plan on using that as a platform to expand into other markets like Nevada,” says Gardner. “And we will be launching the Tikun brand in the Washington market this summer.” Based on the high demand they saw in the Delaware market, Gardner says they plan to launch six unique strains in the American market, with delivery mechanisms like vape products, tinctures, lozenges and topicals in addition to dried flower.

dry cannabis plants
Rows of cannabis plants drying and curing before processing.

While Tikun expands throughout the United States, their sights are set on global expansion, living up to the true meaning of the concept Tikun Olam. They entered a strategic partnership with a licensed producer based in Toronto, bringing their strains, including Avidekel, to the Canadian market. The company they are partnering with, MedReleaf, recently filed for an initial public offering (IPO) on the Toronto stock exchange. Tikun Olam is actively seeking to expand in other parts of the world as well.

Shimadzu Launches Cannabis Analyzer for Potency

By Aaron G. Biros
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On Monday, March 6th, Shimadzu Scientific Instruments, a leading laboratory analytical instrumentation manufacturer, announced the launch of a new product focused on cannabis, according to a press release. Their Cannabis Analyzer for Potency is essentially a high-performance liquid chromatograph (HPLC) packaged with integrated hardware, software, workflows and all the supplies. The supplies include an analytical column, guard columns, mobile phase and a CRM standard mixture.canAnalyzerImg1

The instrument is designed to test for 11 cannabinoids in less time and with greater ease than traditional HPLC instruments. In the press release, they claim “operators are now able to produce accurate results with ease, regardless of cannabis testing knowledge or chromatography experience.” One very unique aspect of the instrument is the lack of experience required to run it, according to Bob Clifford, general manager of marketing at Shimadzu. “We have our typical chromatography software [LabSolutions] with an overlay that allows the user to analyze a sample in three simple steps,” says Clifford. Those in the cannabis industry that have a background in plant science, but not analytical chemistry, could run potency analyses on the instrument with minimal training. “This overlay allows ease of use for those not familiar with chromatography software,” says Clifford.

An overlay of a flower sample with the standards supplied in the High-Sensitivity Method package.
An overlay of a flower sample with the standards supplied in the High-Sensitivity Method package.

The instrument can determine cannabinoid percentages per dry weight in flower concentrates and edibles. “Once you open the software, it will get the flow rate started, heat the column up and automatically begin to prep for analysis,” says Clifford. Before the analysis begins, information like the sample ID number, sample name, sample weight, extraction volume and dilution volume are entered. After the analysis is complete all the test results are reported for each sample.

Because laboratories wouldn’t have to develop quantitative testing methodology, they argue this instrument would save a lot of time in the lab. “After one day of installation and testing, users are equipped with everything they need to obtain cannabis potency results,” states the press release. According to Clifford, method development for potency analysis in-house can take some labs up to three months. “We can bring this instrument to the lab and have it ready for testing almost immediately,” says Clifford. “The methods for this instrument were developed by a team of twenty scientists working on different platforms at our Innovation Center and was tested for ruggedness, repeatability and quantitative accuracy.”

Screenshots from the software on the instrument
Screenshots from the software on the instrument

The instrument’s workflow is designed to meet three methods of analysis depending on testing needs. The High Throughput method package can determine quantities of ten cannabinoids with less than eight minutes per sample. The method was developed in collaboration with commercial testing laboratories. The High Sensitivity method package adds THCV to that target analyte list with ten minutes per analysis. The method provides the sharpest chromatographic peaks and best sensitivity. The High Resolution method package offers full baseline resolution for those 11 cannabinoids in less than 30 minutes per analysis and the ability to add cannabinoids to that target list if regulations change.

The press release states the interface should allow users to reduce the number of steps needed in the analysis and simplify the workflow. The instrument comes with a three-year warranty, preventative maintenance plan and lifetime technical support.

Hoban Law Group Files Lawsuit Against DEA

By Aaron G. Biros
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The Hoban Law Group filed a petition on behalf of three clients against the DEA in the U.S. Court of Appeals for the Ninth District on January 13th, according to a press release. The clients represented by Hoban Law Group in the suit are Hemp Industries Association, RMH Holdings, LLC and Centuria Natural Foods, Inc. The companies are based in California, Colorado and Nevada respectively and are all active in the legal hemp trade. The press release says RMH Holdings “sources its products from industrial hemp lawfully cultivated pursuant to the Agricultural Act of 2014 (also known as the Farm Bill).”

San Francisco's United States Court of Appeals for the Ninth Circuit Photo: Ken Lund, Flickr
San Francisco’s United States Court of Appeals for the Ninth Circuit
Photo: Ken Lund, Flickr

In December, the DEA published a ‘Final Rule’ that classifies cannabis-derived extracts, such as CBD oil, in their own category with a code number to “better track these materials and comply with treaty provisions.” The announcement by the DEA ultimately serves to make any cannabis extract a Schedule 1 narcotic. “Extracts of marihuana will continue to be treated as Schedule I controlled substances,” says the document.

BobHobanAttorney
Bob Hoban, managing partner

Bob Hoban, managing partner of Hoban Law Group says the action is clearly beyond the DEA’s authority. “This Final Rule serves to threaten hundreds, if not thousands, of growing businesses, with massive economic and industry expansion opportunities, all of which conduct lawful business compliant with existing policy as it is understood and in reliance upon the Federal Government,” says Hoban.

The lawsuit states that they want a judicial review of the DEA’s actions “on the grounds that the Final Rule is (1) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, e.g. the CSA, the Farm Bill, and the DEA’s regulations; (2) contrary to constitutional right, power, privilege, or immunity; (3) in excess of statutory jurisdiction, authority, or limitations; and, (4) without observance of procedure required by law.” The suit also claims that the ‘Final Rule’ conflicts with other federal laws like the Data Quality Act, Regulatory Flexibility Act and Congressional Review Act.

According to Garrett Graff, associate attorney at Hoban Law Group, the entire Cannabis genus is not unlawful and the DEA is overstepping its authority. “As the Ninth Circuit found in 2003 and 2004 there are certain parts of the plant like the stalk and seed that are congressionally exempted from the Controlled Substances Act and thus the DEA’s rulemaking authority,” says Graff. “By creating a drug code for ‘marihuana extract’, the DEA is saying that they are a controlled substance, but that goes against a number of existing laws.”

Garrett Graff, associate partner at Hoban Law Group
Garrett Graff, associate partner at Hoban Law Group

The definition of ‘marihuana extract’ under the ‘Final Rule’ also references extracts containing one or more cannabinoids, which goes beyond the realm of cannabis altogether, according to Graff. “The DEA and many other sources have acknowledged and confirmed that cannabinoids can be derived from other varieties of flowers, cacao and other sources, making it virtually impossible to distinguish which cannabinoids would be subject to this drug code,” says Graff. “The DEA’s rule effectively makes the presence of cannabinoids a determinative factor of a controlled substance, which is inconsistent with what Congress has said.”

The petition filed is essentially the initiation or commencing of a lawsuit. Graff says their case is rooted in statute. “We hope to accomplish a striking of the rule, permanent injunction of the rule and for the DEA to engage in the appropriate processes and procedures when making rules in the future,” says Graff. “Alternatively, an amendment to the rule to make the definition of ‘marihuana extract’ consistent with existing law and reflect those portions and varieties of the plant which are in fact lawful could be considered.” It may still be roughly 30 days before the DEA responds with briefing and possibly an oral argument to follow on the various issues surrounding the petition, says Graff. The Ninth Circuit petition, including briefings and hearings, is likely to take at least several months.

The Practical Chemist

Potency Analysis of Cannabis and Derivative Products: Part 2

By Rebecca Stevens
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As mentioned in Part 1, the physiological effects of cannabis are mediated by a group of structurally related organic compounds known as cannabinoids. The cannabinoids are biosynthetically produced by a growing cannabis plant and Figure 1 details the biosynthetic pathways leading to some of the most important cannabinoids in plant material.

Potency figure 1
Figure 1: The biosynthetic pathway of phytocannabinoid production in cannabis has been deeply studied through isotopic labeling experiments

The analytical measurement of cannabinoids is important to ensure the safety and quality of cannabis as well as its extracts and edible formulations. Total cannabinoid levels can vary significantly between different cultivars and batches, from about 5% up to 20% or more by dry weight. Information on cannabinoid profiles can be used to tailor cultivars for specific effects and allows end users to select an appropriate dose.

Routine Analysis vs. Cannabinomics 

Several structurally analogous groups of cannabinoids exist. In total, structures have been assigned for more than 70 unique phytocannabinoids as of 2005 and the burgeoning field of cannabinomics seeks to comprehensively measure these compounds.¹

Considering practical potency analysis, the vast majority of cannabinoid content is accounted for by 10-12 compounds. These include Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD), cannabigerol (CBG), Δ9-tetrahydrocannabivarian (THCV), cannabidivarin (CBDV) and their respective carboxylic acid forms. The cannabinoids occur primarily as carboxylic acids in plant material. Decarboxylation occurs when heat is applied through smoking, vaporization or cooking thereby producing neutral cannabinoids which are more physiologically active.

Potency Analysis by HPLC and GC

Currently, HPLC and GC are the two most commonly used techniques for potency analysis. In the case of GC, the heat used to vaporize the injected sample causes decarboxylation of the native cannabinoid acids. Derivatization of the acids may help reduce decarboxylation but overall this adds another layer of complexity to the analysis² ³. HPLC is the method of choice for direct analysis of cannabinoid profiles and this technique will be discussed further.

A sample preparation method consisting of grinding/homogenization and alcohol extraction is commonly used for cannabis flower and extracts. It has been shown to provide good recovery and precision² ³. An aliquot of the resulting extract can then be diluted with an HPLC compatible solvent such as 25% water / 75% acetonitrile with 0.1% formic acid. The cannabinoids are not particularly water soluble and can precipitate if the aqueous percentage is too high.

To avoid peak distortion and shifting retention times the diluent and initial mobile phase composition should be reasonably well matched. Another approach is to make a smaller injection (1-2 µL) of a more dissimilar solvent. The addition of formic acid or ammonium formate buffer acidifies the mobile phase and keeps the cannabinoid acids protonated.

The protonated acids are neutral and thus well retained on a C18 type column, even at higher (~50% or greater) concentrations of organic solvent² ³.

Detection is most often done using UV absorbance. Two main types of UV detectors are available for HPLC, single wavelength and diode array. A diode array detector (DAD) measures absorbance across a range of wavelengths producing a spectrum at each point in a chromatogram while single wavelength detectors only monitor absorbance at a single user selected wavelength. The DAD is more expensive, but very useful for detecting coelutions and interferences.

References

  1. Chemical Constituents of Marijuana: The Complex Mixture of Natural Cannabinoids. Life Sciences, 78, (2005), pp. 539
  2. Development and Validation of a Reliable and Robust Method for the Analysis of Cannabinoids and Terpenes in Cannabis. Journal of AOAC International, 98, (2015), pp. 1503
  3. Innovative Development and Validation of an HPLC/DAD Method for the Qualitative and Quantitative Determination of Major Cannabinoids in Cannabis Plant Material. Journal of Chromatography B, 877, (2009), pp. 4115

Rebecca is an Applications Scientist at Restek Corporation and is eager to field any questions or comments on cannabis analysis, she can be reached by e-mail, rebecca.stevens@restek.com or by phone at 814-353-1300 (ext. 2154)

OHA Addresses Oregon Growing Pains, Changes Testing Rules

By Aaron G. Biros
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Last week, the Oregon Health Authority (OHA) published a bulletin, outlining new temporary testing requirements effective immediately until May 30th of next year. The changes to the rules come in the wake of product shortages, higher prices and even some claims of cultivators reverting back to the black market to stay afloat.img_6245

According to the bulletin, these temporary regulations are meant to still protect public health and safety, but are “aimed at lowering the testing burden for producers and processors based on concerns and input from the marijuana industry.” The temporary rules, applying to both medical and retail products, are a Band-Aid fix while the OHA works on a permanent solution to the testing backlog.

Here are some key takeaways from the rule changes:

Labeling

  • THC and CBD amounts on the label must be the value calculated by a laboratory, plus or minus 5%.

Batch testing

  • A harvest lot can include more than one strain.
  • Cannabis harvested within a 48-hour period, using the same growing and curing processes can be included in one harvest lot.
  • Edibles processors can include up to 1000 units of product in a batch for testing.
  • The size of a process lot submitted for testing for concentrates, extracts or other non-edible products will be the maximum size for future sampling and testing.

    Oregon Marijuana Universal Symbol for Printing
    Oregon Marijuana Universal Symbol for Printing

Sampling

  • Different batches of the same strain can be combined for testing potency.
  • Samples can be combined from a number of batches in a harvest lot for pesticide testing if the weight of all the batches doesn’t exceed ten pounds. This also means that if that combined sample fails a pesticide test, all of the batches fail the test and need to be disposed.

Solvent testing

  • Butanol, Propanol and Ethanol are no longer on the solvent list.

Potency testing

  • The maximum concentration limit for THC and CBD testing can have up to a 5% variance.

Control Study

  • Process validation is replaced by one control study.
  • After OHA has certified a control study, it is valid for a year unless there is an SOP or ingredient change.
  • During the control study, sample increments are tested separately for homogeneity across batches, but when the control study is certified, sample increments can be combined.

Failing a test

  • Test reports must clearly show if a test fails or passes.
  • Producers can request a reanalysis after a failed test no later than a week after receiving failed test results and that reanalysis must happen within 30 days.
Gov. Kate Brown Photo: Oregon Dept. of Transportation
Gov. Kate Brown
Photo: Oregon Dept. of Transportation

The office of Gov. Kate Brown along with the OHA, Oregon Department of Agriculture (ODA) and Oregon Liquor Control Commission (OLCC) issued a letter in late November, serving as a reminder of the regulations regarding pesticide use and testing. It says in bold that it is illegal to use any pesticide not on the ODA’s cannabis and pesticide guide list. The letter states that failed pesticide tests are referred to ODA for investigation, which means producers that fail those tests could face punitive measures such as fines.

Photo: Michelle Tribe, Flickr
Photo: Michelle Tribe, Flickr

The letter also clarifies a major part of the pesticide rules involving the action level, or the measured amount of pesticides in a product that the OHA deems potentially dangerous. “Despite cannabis producers receiving test results below OHA pesticide action levels for cannabis (set in OHA rule), producers may still be in violation of the Oregon Pesticide Control Act if any levels of illegal pesticides are detected.” This is crucial information for producers who might have phased out use of pesticides in the past or might have began operations in a facility where pesticides were used previously. A laboratory detecting even a trace amount in the parts-per-billion range of banned pesticides, like Myclobutanil, would mean the producer is in violation of the Pesticide Control Act and could face thousands of dollars in fines. The approved pesticides on the list are generally intended for food products, exempt from a tolerance and are considered low risk.

As regulators work to accredit more laboratories and flesh out issues with the industry, Oregon’s cannabis market enters a period of marked uncertainty.