Tag Archives: cbd

June 29, 2016

Going Beyond the Strain Names with PotBot

By Aaron G. Biros

David Goldstein, co-founder and chief executive officer of PotBotics, launched a medical cannabis recommendation engine called PotBot with the goal to better inform patients to target their conditions with more accurate recommendations based on scientific research. “This is a tool to help move the market away from the thousands of strain names that are mainly just marketing or branding indicators,” says Goldstein. The medical application is designed to inform patients on peer-reviewed data, research on the treatment of their ailments with cannabis and the specific cannabinoids that are necessary for treating their condition. They began development on PotBot in October of 2014, launching the beta version to 400 users in November of 2015. On April 20^th, 2016, Goldstein launched officially in the Apple Store, and the program will be available on Android in July.

goldstein potbot — David Goldstein (left) alongside co-founder, Baruch Goldstein (right)

Rather than focusing on strain names, PotBot focuses on the cannabinoid values to help patients gain an understanding of the correlation between which compounds might best target their condition. “This is a great tool for patients trying to familiarize themselves with what strains might work best,” says Goldstein. “For example, insomnia patients generally need cannabis with higher CBN levels, so we first educate the patient on cannabinoid ranges to shoot for and what strains might help. PotBot would recommend the strain Purple Urple because it is an indica found to have higher CBN values,” adds Goldstein. The program goes into great detail with the patient’s preferences including everything down to consumption methods so they know why it might recommend certain strains.

A screenshot showing a recommended cannabinoid ratio for a patient

The recommendation tool is accessible via kiosks at dispensaries, on a desktop version for the computer as well as on the Apple Store for iPads and iPhones. “I do not see it as a way of replacing budtenders, rather supplementing them with knowledge,” says Goldstein. PotBot is designed as a tool to supplement the budtender’s understanding of cannabis, so the budtender does not need to know everything off the top of their head or recommend strains based on anecdotal information, according to Goldstein.

Goldstein’s team at PotBotics performed extensive research prior to launching PotBot, spending two years doing strain testing to develop the program. “There is currently no regulatory body [for strain classification] so we took it upon ourselves to work with the best testing laboratories for truly robust analyses and properly vetted growers to get the most valid data,” says Goldstein. “The current strain classification system and nomenclature is rather unscientific so we focus on cannabinoid values and soon we will be able to incorporate terpene profiles in the recommendation.” Moving away from the common focus on taste, smell and other qualitative values, they focus on medical attributes of cannabinoid profiles because they have the most peer-reviewed research available today.

As an OEM, the company designed the tool to work with each dispensary’s inventory, to provide recommendations for strains that a patient can access on site, however anyone can access the recommendation tool for free at PotBot.com. Goldstein’s company and their mission represent an important development in the cannabis industry; this could begin a key transition from thousands of understudied strain names to a more scientific and calculated method to treating patients’ conditions with cannabis.

June 14, 2016

Marijuana Matters

Patent Options Available for Breeding Cannabis

By David C. Kotler, Esq.

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Patent No.: 909554. Date of patent: August 4, 2015. Years from now, historians and academics may look back on this patent number and date as a watershed mark in the evolution of legal cannabis. Feel free to read the 147 pages of the patent documents but, in short, it “leads to many innovations, provides compositions and methods for breeding, production, processing and use of specialty cannabis.” It was the first time that the U.S. Patent Office (USPTO) had issued a patent for a plant containing significant amounts of THC. One USPTO spokesman recently discussed with a journalist that “there are no special statutory requirements or restrictions applied to marijuana plants.” The following is a broad, and I mean really broad, overview of the options available to protect intellectual property within the cannabis species and strain realm.

Generally speaking, to be patent eligible, an invention must be useful, it must be new, it cannot be obvious and it must be described in a manner so that people of skill in the relevant specialty can understand what the invention is, make it and use it without engaging in undue experimentation. In terms of cannabis, essentially the breeder must have created a new and non-obvious strain over what already exists that is useful such as being highly resistant to molds or having a specific concentration of CBD.

Breeders potentially have a number of options available to them, despite the common belief otherwise. In the U.S. there are five types of intellectual property protection that breeders can obtain for new plant varieties or their use of clones:

One may seek protection for seeds and tubers, known as Plant Variety Protection. A tuber is essentially a swelled root that forms a storage organ. The Plant Variety Protection Office provides this protection. To apply for Plant Variety Protection, the applicant submits information to show that the variety is new, distinct, uniform and stable.

For asexually propagated plants except for tubers, a Plant Patent may be sought. These are sought through the USPTO. This is relatively inexpensive compared with a Utility Patent covering the genetics.

Trade secrets are often used to protect inventions that will not be commercially available or cannot be reverse engineered. For example, if a new strain is invented but is only commercially available in its final form, trade secret protection may be the best form. The most important thing to remember is that a company must follow a strict set of requirements to keep the trade secret confidential.

The last patent type protection could be through a Utility Patent. A Utility Patent can be issued for any type of plant showing its utility. These are issued by the USPTO. Seeking and obtaining a Utility Patent is expensive and complex.

In addition to Patent Protection, breeders may seek Contractual Agreements restricting the use of the clones (i.e. a material use agreement). The parameters that a breeder wishes to craft can essentially be crafted into the language of any type of agreement that is drafted to memorialize the relationship and terms between the parties.

A few broad-stroke items to keep in mind with regard to patents particularly relative to the patenting of cannabis strains and the like: First, is the passage of the America Invents Act which among other changes allowed for the U.S. to transition from a First-to-Invent patent system to a system where priority is given to the first inventor to file a patent application. Second, there are the potential bars based on different types of prior use.

Any discussion about the foregoing topic should necessarily include the question: Is it really good for the cannabis industry and its evolution? The dialogue moves out of one steeped in tradition, lure of trips through mountain passages, and potentially patient benefit or in search of higher quality and into connotations of business law and big businesses sweeping in to take over. It is an expensive process. It may be inevitable. In the meantime, protect yourself as best you can and as you see fit.

May 12, 2016

CannaGrow: Education on the Science of Cultivation

By Aaron G. Biros

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The CannaGrow Conference & Expo, held in San Diego on May 7^thand 8^th, educated attendees on the science of cannabis cultivation. The conference brought subject matter experts from around the country to discuss cannabis breeding and genetics, soil science and cultivation facility design.

Discussions at the conference delved deep into the science behind growing while providing some expert advice. Drew Plebani, chief executive officer of Commercial Cultivator, Inc., gave a comprehensive review of soil ecology and how understanding soil fertility is crucial to successfully growing consistent cannabis. “Soil fertility is measured by laboratories in terms of soil minerals, plant-available nutrients, percent of organic materials, pH levels and most importantly the balance of the soil’s chemical makeup,” says Plebani. “There is no silver bullet in soil ecology; increasing your soil fertility comes down to understanding the composition of soil with analytical testing.” Plebani went on to add that soil systems for cannabis need to be slightly fungal-dominant in developing an endomycorrhizal system, which is optimal for cannabis plant growth.

Plebani notes that growth and viability are reliant on maximum root mass.

Tom Lauerman, colloquially known as Farmer Tom and founder of Farmer Tom Organics, kicked off the conference with an introduction to cultivation techniques. Lauerman also delved into his experience working with federal agencies in conducting the first ever health hazard evaluation (HHE) for cannabis with the National Institute for Occupational Safety and Health (NIOSH). Through the HHE program, NIOSH responds to requests for evaluations of workplace health hazards, which are then enforced by the Occupational Safety & Health Administration (OSHA). Lauerman worked with those federal agencies, allowing them to tour his cultivation facilities to perform an HHE for cannabis processing worker safety. “I was honored to introduce those federal agencies to cannabis and I think this is a great step toward normalizing cannabis by getting the federal government involved on the ground level,” says Lauerman. Through the presentation, Lauerman emphasized the importance of working with NIOSH and OSHA to show federal agencies how the cannabis production industry emerged from the black market, branding itself with a sense of legitimacy.

Attendees flocked to Jacques and his team after the presentation to meet them.

Adam Jacques, award-winning cultivator and owner of Grower’s Guild Gardens, discussed his success in breeding CBD-dominant strains and producing customized whole-plant extractions for specific patients’ needs. “I find higher percentages of CBD in plants harvested slightly earlier than you would for a high-THC strain,” says Jacques. “Using closed-loop carbon dioxide extraction equipment, we can use multiple strains to homogenize an oil dialed in for each patient’s specific needs.” As a huge proponent of the Entourage Effect, Jacques stressed the importance of full plant extraction using fractionation with carbon dioxide. He also stressed the importance of analytical testing at every step during processing.

Hildenbrand discussing some of the lesser-known terpenoids yet to be studied.

Zacariah Hildenbrand, Ph.D., chief scientific officer at C4 Laboratories, provided the 30,000-foot view of the science behind compounds in cannabis, their interactions and his research. With the help of their DEA license, he started the C4 Cannabinomics Collaborative, where they are working with Dr. Kevin Schug at the University of Texas-Arlington to screen various cannabis strains to discover new molecules and characterize their structure. “Secondarily, we are using gene expression profiles and analysis to understand the human physiological response and the mechanism through which they elicit that response,” says Hildenbrand. “As this research evolves, we should look to epigenetics and understanding how genes are expressed.” His collaborative effort uses Shimadzu’s Vacuum Ultraviolet Spectroscopy (VUV), and they use the only VUV instrument in an academic laboratory in the United States. “Pharmaceuticals are supposed to be a targeted therapy and that is where we need to go with cannabis,” says Hildenbrand. Him and his team at C4 Laboratories want to work on the discovery of new terpenes and analyze their potential benefits, which could be significant research for cannabis medicine.

Other important topics at the conference included facility design and optimization regarding efficient technologies such as LED lighting and integrated pest management.

May 4, 2016

Marijuana Matters

Let’s Talk CBD

By David C. Kotler, Esq.

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Let’s talk about cannabidiol, CBD, a non-psychoactive component of cannabis. Let’s not talk about CBD from the whole plant. This is a conversation about the proliferation of hemp-based CBD marketed everywhere from gas stations to specialty health and wellness stores. Heck, “its legal in all 50 states”, right?

On the Federal Level, pursuant to Title 21 USC 802 Section (16) The term “marijuana” means all parts of the plant cannabis sativa L., whether growing or not; the seeds thereof; the resin extracted from any part of such plant; and every compound, manufacture, salt, derivative, mixture, or preparation of such plant, its seeds or resin. The term does not include the mature stalks of such plant, fiber produced from such stalks, oil or cake made from the seeds of such plant, any other compound, manufacture, salt, derivative, mixture, or preparation of such mature stalks (except the resin extracted therefrom), fiber, oil, or cake, or the sterilized seed of such plant which is incapable of germination.

Proponents of the position that hemp-derived CBD is legal point to the lack of a specific definition under the above description (often asserting that their oil is not processed from the flower) and the Ninth Circuit’s opinion in Hemp Indus. Ass’n v DEA, 333 F.3d 1082 (9^th Cir. 2003). They buttress their belief by citing the DEA’s clarification of hemp in the Federal Register released in October 2001 and the 2013 Farm Bills’ adoption of the following definition of industrial hemp (adopted from plant scientists research in the 70’s: “The term ‘industrial hemp’ means the plant, cannabis sativa L. and any part of such plant, whether growing or not, with a delta-9 tetrahydrocannabinol H. R. 2642—265 concentration of not more than 0.3 percent on a dry weight basis.” Much of the foregoing has been extended to even support opinions that hemp-derived CBD from domestic sources under the 2013 Farm Bill is legal for distribution nationwide.

Opponents of the hemp-derived CBD is legal argument (putting aside the issues with imported hemp and contaminants, etc.) point to the exception in the definition of “marijuana” i.e. to actually get a workable form of CBD from hemp, the preparation of the stalk puts you into the resin category which is excepted from the terms that are specifically not included in “marijuana.” In regard to HIA v. DEA cited above, opponents posit that the court decision, never mentions CBD, and the HIA maintain that this ruling did not legalize CBD.

In February 2015 and again in February 2016 the FDA issued warning letters to CBD companies. The overall context of the letters dealt with mislabeling and improper claims in addition to the most recent round of letters addressing CBD products’ exclusion from the dietary supplement definition under the FD&C act and how that is affected by CBD’s consideration as a new drug in one or more new drug applications. What has not been addressed or asserted by the FDA is the legal status of CBD under the Controlled Substances Act.

Although I have seen many commentators and attorneys opine on the legality as the case may be of hemp-derived CBD and its ability to be shipped to and sold in all 50 states (often with a caveat that readers should consult them for further advice), I have never seen the issue addressed from a practitioner that deals with the United States Patent and Trademark Office. I am not that practitioner. However, I do represent a company that has recently made application. I, not being a trademark attorney, but being sensitive to the federal government’s position collectively on CBD, found the examiner’s questions in her Office Action Letter surrounding CBD to be quite interesting. They were as follows:

Do applicant’s identified goods contain marijuana, marijuana based preparations, or marijuana extracts or derivatives, synthetic marijuana, or any other illegal controlled substances?
If the applicant’s goods contain Cannabidiol (CBD), is this derived from marijuana or from industrial hemp?
Are the applicant’s goods lawful pursuant to the Controlled Substances Act?

I searched for another application and Office Action Letter from 2016 for another CBD product (both were vaporizer products rather than the lotions, balms, etc. that have been the subject of other applications). The questions to that applicant mirrored those above.

What I take from the questions that trademark examiners are asking is that perhaps the debate raging in academic and legal circles is for naught. It looks like at least the USPTO has resigned itself to there being a difference between cannabis or whole plant and hemp-based CBD in terms of definition and proscription under the federal controlled substances act.

So we have come full circle in my question, ‘Is it legal in all fifty states?’ If you answer yes to that question then please provide me the definition of marijuana/cannabis from the Controlled Substance Act from each of the fifty states individually and a copy of the documentation from a source showing how the industrial hemp was grown and processed and verifiable lab reports of the particular product’s contents.

March 7, 2016

Researching Cannabis Genetics: A Q&A with CJ Schwartz, Ph.D.

By Aaron G. Biros

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Studying cannabis genetics is a convoluted issue. Strain classification, medicinal effects and plant breeding are particular areas in the science of cannabis that still require heavy research. Marigene, a company researching cannabis genetics, is currently working with universities and research institutes to help map the cannabis genome and catalog genetic variation.

CJ Schwartz, Ph.D.

According to CJ Schwartz, Ph.D., chief executive officer and founder of Marigene, their mission is to “to classify, certify, and improve cannabis.” After studying genetics and cellular biology at the University of Minnesota, Schwartz received his Ph.D. in biochemistry from the University of Wisconsin. His research in the past decade has focused on genetic variations that control flowering time, discovering the expression of a gene called Flowering Locus T leads to differential flowering time of plants and is dependent on their native locations. We sat down with Schwartz to learn more about his research and collaborative efforts.

Cannabis Industry Journal: Why are you researching mapping the cannabis genome?

CJ Schwartz, Ph.D: We seek to identify the genetic differences among cannabis strains and the genes responsible for these differences. Genetic differences are what cause different strains to have different effects. DNA allows reproducibility, consistency, and transparency for your cannabis strains.

The more information we gather about cannabis genetics, the more tools we have available to create tailored strains. Cannabis is a targeted compound. It interacts with a very specific system in the human body, similar to hormones, such as insulin. Understanding the cannabis genome will help bring legitimacy and integrity to cannabis products, and allow us to better understand how chemicals from cannabis interact with the human brain. Genetic identification can provide a method of certification to more comprehensively describe plant material.

Schwartz doing sample preparation on the lab bench.

CIJ: How did you get involved in cannabis research?

Schwartz: My interest in cannabis guided my research career. Cannabis may not be a cure-all, but it has significant and measurable medicinal effects for many patients.

To allow true development of cannabis products, we need more science! Our genetic analysis is required for normalization and acceptance of cannabis products, but also essential for future breeding efforts to develop better and more useful plants.

Our sister company, Hempgene, is applying all of the same technology and techniques for hemp research. One focus of Hempgene is to manipulate flowering time in select hemp cultivars so that they mature at the appropriate time in different environments.

CIJ: What do you hope to accomplish with your research?

Schwartz: We can develop or stabilize a plant that produces a very specific chemical profile for a specific condition, such as seizures, nausea or pain. By breeding plants tailored to a patient’s specific ailment, a patient can receive exactly the medicine that they need and minimize negative side effects.

The current term describing the interaction of cannabis compounds is called the entourage effect. Interactions among compounds can be additive or synergistic. The entourage effect describes synergistic effects, where small amounts of compound A (e.g. Myrcene) vastly increase the effects of compound B (e.g. THC). Instead of flooding one’s body with an excessive amount of chemicals to get a non-specific effect, cannabis plants can be bred to produce a very specific effect.

A view of some of the work stations inside the laboratory at Marigene.

Currently our goal is to catalog the natural genetic variation of cannabis, and to identify DNA changes that affect a trait of interest. Once superior variants of a gene are identified, those variants can be combined, by marker-assisted breeding, to produce new combinations of genes. How different cannabis chemicals interact to produce a desired effect, and how different human genetics influence the efficacy of those chemicals should be the ultimate goal of medical marijuana research.

We are working closely with academic institutions and chemical testing labs to gather data for establishing correlations between specific cannabis strains and desirable chemical profiles. Our closest collaborator, Dr. Nolan Kane at UC-Boulder, is working to complete the Cannabis genomic sequence and generate the first high- resolution cannabis genetic map.

We are currently accepting samples and we produce a report in roughly two to three months. For one sequencing run, we identify 125 million pieces of DNA that are 100 base pairs long. We get so much information so there is a considerable time commitment.

February 22, 2016

Adam Jacques: Award-Winning Grower, Pioneer and Medical Cannabis Provider

By Aaron G. Biros

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Walking into one of the grow rooms on Adam Jacques’ farm outside of Eugene, Oregon, you will find dozens of cannabis plants and a whiteboard on the wall with the note “Do it for Frank” across the top. This is a reminder of why Jacques and his team are growing medical marijuana: To help people.

doitforfrank — Above some notes is their daily inspiration: “Do it for Frank”

Frank Leeds, one of Jacques’ cannabis patients, lost his battle with cancer in early January.

adamJgrow — A view of the grow room where they have 48 plants in flowering..

Jacques was working with Frank for the past five years to develop “Frank’s Gift,” a high-cannabidiol (CBD) strain with a slew of potential medical benefits. Deeply saddened by the loss of his patient and close friend, Jacques continues to run his grow operation, Grower’s Guild Gardens, where he and his wife, Debra, work to get high-quality, safe medicine to their patients.

His patients and other publications have repeatedly referred to Jacques as a “legend.” Jacques previously won Canna Magazine’s award for Most Influential Grower in the Northwest.

On their farm, strain testing is currently underway for the upcoming changes in the recreational program in Oregon. “With the way the medical laws are now, I have 48 plants for my patients, including multiple high-CBD genetics, and any excess flower will be sold to recreational dispensaries to cover our overhead costs,” says Jacques. When the Oregon Liquor Control Commission (OLCC) grants them their recreational grow license, he will take some of those trial strains to an outdoor crop estimated to be in the thousands of plants on his 42-acre farm.

Presenting at the Dispensary Next Conference a few weeks ago, Jacques said to a crowded room of industry professionals: “The biggest reward is helping people.” Jacques and his team’s work exemplifies the good that smaller grow operations can do for the industry.

plantsjacques — This plant is roughly four weeks from harvest, currently in the flowering stage.

Jacques’ recent work has taken him to help Leni Young, a four-year-old girl originally from Alabama who suffers from debilitating seizures. Her parents became medical refugees when she was not selected for an Alabama study involving cannabis oil. As a result, the Young’s took their daughter to Eugene, where with the help of Jacques and his team, they could get her customized cannabis oil with high doses of CBD and tetrahydrocannabinolic acid (THC-A) that could help treat her seizures.

The cannabis oil that Jacques created has brought Young’s seizures down from multiple occurring every day to just one every six weeks. “One-strain solutions like ‘Charlotte’s Web’ are no longer the answer for treating medical conditions,” says Jacques. “We create something custom designed for individual patients, and it is working.” CBD and THC-A, the main active ingredients in Leni’s medicine, are two of the non-psychoactive compounds in cannabis believed to have extraordinary medical benefits.

jacquesinspect — Jacques inspecting some of the different strains they are testing for the recreational program.

Less than three weeks ago, a bill was introduced to the Alabama legislature that would decriminalize the possession of and allow patients to get high-CBD oil. The bill is called “Leni’s Law.”

Jacques’ goal in the long term is to get clinical trials with peer-reviewed studies to connect the dots between his patients, cannabis and evidence-based medicine. “I am working with a laboratory in Arizona and a doctor from Israel to perform a peer-reviewed study,” he adds. “Getting peer-reviewed will allow me to provide legitimate scientific evidence for my claims and get the knowledge into the hands of my patients.”

Looking into the immediate future, Jacques is wary of different regulations coming to Oregon. “Once you go recreational with your business, you lose the ability to provide any sort of a medical recommendation,” says Jacques. “I do not want to see the recreational program and the desire for profits push out our ability to help patients.”

Jacques and his team represent the idea that embodies the cannabis legalization movement, which is to help people get the medicine they need. “The money is not really important any more,” says Jacques.

December 3, 2015

Consumer Trends: Analyzing Oregon’s Dynamic Markets

By Aaron G. Biros

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Oregon was the second state to legalize medical marijuana in 1998 behind California that introduced legislation measures two years earlier in 1996. In the past two decades, Oregon has grown its medical market, treating more patients and producing exponentially more cannabis. Since October 1^st of 2015, Oregon’s recreational sales have been made legal, creating potential opportunities for dispensaries to target this emerging market.

In that first week of recreational sales alone, dispensaries in Oregon made over $11 million in revenue. That figure is more than double what Colorado made in its first week and significantly larger than Washington’s figures posted.

puregreenpdx — The exterior storefront of PureGreen in Northeast Portland, Oregon

Matt Walstatter, president and founder of PureGreen, a dispensary located in Northeast Portland, Oregon, says that while recreational customers are limited to seven grams of flower per day (no concentrates or edibles yet), they have noticed an uptick in sales of certain strains.

“Up until October 1^st of this year, our sales percentages have been very consistent with about 66% to 72% flower sales since we opened and around 20% concentrates and 10% edibles, with the remainder consisting of topicals and non-medicated products,” says Walstatter. “Now we have an influx of a new type of customer so we do around 80% of sales in flower since the introduction of recreational sales on October 1^st.”

When analyzing the top-selling strains, Walstatter’s figures show an inclination of customers and patients to prefer high-THC strains when buying flower. Girl Scout Cookies, a very high THC, low CBD strain, consistently sells the most at over 2000 grams per month. “People that smoke flower generally want high-THC strains, while people that seek CBD overwhelmingly do not smoke as much and prefer ingesting edibles, tinctures, capsules or other products with low THC content,” adds Walstatter.

PureGreen keeps a select few high-CBD strains on their shelves, including Cannatonic, which is known for its approximate 1:1 ratio of THC to CBD. “Out of twenty five strains on my shelves, I usually keep two or three high-CBD strains because they have their niche, even if they are less sought after, it is certainly worthwhile to carry them,” says Walstatter.

“Because Oregon has such a well established cannabis culture with less novice customers than other markets, our more popular strains are consistent over multiple months so we built a brand around knowledge and education,” Walstatter says. “Our budtenders usually come from a background involving the plant whether they were involved in cultivation, trimming or processing, and then they go through extensive training to be able to recommend certain strains for different ailments or preferences.”

Walstatter offered some tips for dispensary owners and employees at the Las Vegas Marijuana Business Conference in November where he sat on a panel with other industry experts called What Patients and Consumers Want: Strain Trends, Product Mix & CBD vs. THC. “Understanding your customer’s needs and their buying habits plus properly managing your inventory is the key to success,” says Walstatter. “We have a couple of exclusive growers that went through an extensive review process, they tend to rotate through different strains while we have some grower-specialists that grow only one strain very consistently.”

Walstatter prides himself in his team’s exceptional customer service. “People do business with people they know, like and trust, so authenticity is very important to us,” he adds. “Over delivering on value in the form of knowledge, expertise and service is crucial to growing your brand and business.” Having a high quality product mix, knowledgeable staff and inviting atmosphere are a few of the ingredients to running a successful dispensary.

“It can take up to six months or longer to bring a new strain from seed to sale, so if it is a popular strain, it is very important to have a backup grower,” Walstatter adds. He likens his dispensary to a farm-to-table restaurant where the menu is constantly changing: “This time of year, there are some greenhouse and outdoor crops that do well on the shelves but strains can go in and out of season.”

While edibles and concentrates are not yet available for recreational sales, state regulators are closely monitoring other state’s rules and progress to map out a timeline for their introduction. This would effectively create another new emerging market, opening up potential opportunities for dispensaries in Oregon to diversify.

October 28, 2015

BEST Extractions

Defining BEST Extraction

By John A. Mackay, Ph. D.

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Over the next few months, I would like to walk through a series of articles to cover the number of ways to extract potentially pharmaceutically active compounds from cannabis plants. However, in the first article I would like to review concerns being addressed in state regulations: contamination in concentrates with pesticides, mycotoxins, and residual solvents. The next article will cover the most common extraction with two different modes: CO2 versus hydrocarbons.

Currently, there is a lot of focus on the cannabis strain of hemp. This is defined as having less than 0.3% of THC, (the psychoactive compound). To be clear, the science of extraction is eons old, but the current revitalization is due to new scientific inquiry regarding the applications of the cannabis plant.

I am often asked, “What is the ‘best’ extraction for a natural product?” The BEST extraction? The key to this answer is that you must assume unintended consequences until you can prove that they are at least minimized compared to the intended consequences.

I have a suggestion for you to consider and I look forward to your response to it. I also assume the right to adapt and revise it.

Botanical integrity from seed to shelf

Efficacy of the process beyond efficiency, economics, effectiveness

Safety of people and product

Testing for confirmation at each step of process

The hemp industry has changed significantly over the past few years. Just casually flipping through the channels on television, reading a newspaper or magazine, (on any topic – news, business, sports, food and science) and there is some facet of hemp’s value being examined. The reduction of traditional pulmonary intake (smoking) in the legal marketplace can be tracked by sales of these products in the states where it is legal. The balance of ingestion is drastically tipping toward what might still be considered smoking with vaporizer products as well as toward edible consumables. The ingredients in these products come not from just adding the plant to the formulation, but rather a concentrated mixture. This is the difference between adding a raw vanilla and a teaspoon of vanilla extract. The compound getting the most coverage is cannabidiol (CBD), which is the compound derived from cannabidiolic acid (CBDA). The effects of the other compounds in the plant are being studied as well.

Unintended consequences from the concentration – extraction – are something we need to consider seriously as consumers. The labeled use of “natural” is one that is critical, but can be totally nullified by the unintended contamination in the extraction workflow. Years of making sure the hemp adheres to strict growing environment can be destroyed in seconds with the addition of polycyclic aromatic hydrocarbons (PAH’s) by the use of solvent that has these toxic chemicals in them. These come not through intended consequences, but not knowing the stabilizers and other additives in material being added to these previously pure plants.

What if I pour sour milk on a natural granola for breakfast? What if I use water with high lead or contaminated water to pour over natural coffee grind? Not a great way to start the day, but it is no different than using the most premium hemp and unknowingly adding low grade solvents or adding components from cleaning the surfaces of instruments that come in contact with hemp.

Note that, by definition, we are concentrating the material from the hemp plant. From 4,000 grams, we are getting 400 grams of CBDA if it is 10% by weight (and later converted to CBD). That compound is 10 times more concentrated in a solution. What other compounds are now also 10 times or 5 times or 100 times more concentrated? Maybe no “bad” ones, but how do you know that something else is not also in the mixture?

figure1 extract — Figure 1. With each step of concentration of the green balls, so it could be with other components in the mixture.

This is illustrated in the filtering of green balls in Figure 1. As the green balls become a greater and greater percentage of the solution, it is possible that other compounds like pesticides are also increasing in percentage of the extraction solution. The solution is more concentrated and “simpler” versus all of the other things in the original mixture.

The simple answer is in the testing of the components. The labeling of major compounds is only the beginning of what is on the label that you read. Heavy metals? PAH’s? Residual solvents? Pesticides? Molds? And a long list of other material that could come into the process after the plant left its pristine organic farm. Many studies can be read about slip agents in bags, contamination from workers in the workflow, and other sources of inconsistency.

There are a significant number of companies that I have seen that take this very seriously. New companies are being formed that have safety of product at the top of the list of importance. They are building facilities that are sterile and putting standard operating procedures in place that continually test the product along every step to ensure that they are in compliance.

ecxtractionfig2 — Figure 2. Science and economics merge when considering all the possible uses of concentrated compounds to final product formulations

Supercritical fluid extraction is GRAS (generally regarded as safe). It is, only as long as the solvent specifications are known, the vendor meets those standards, and the instrument surfaces meet any necessary standards.

Supercritical carbon dioxide is used to clean surfaces of electronics and bones for skin grafts. It is used for the decaffeination of coffee as well as pulling trace amounts of pesticides from soil. It is used to extract antioxidants from krill and the active ingredients from algae as well as oil from core samples deep below the earth. It also extracts the terpenes and CBDA from hemp – as well as possibly anything that has been added to it.

The key take away from this article is to know the BEST extraction.

Botanical integrity from seed to shelf

Efficacy of the process beyond efficiency, economics, effectiveness

Safety of people and product

Testing for confirmation

Taking each of these into consideration will bring the best results for concentrations of hemp products. I hope you can extract the best from your day.