Tag Archives: safety

October 21, 2019

3 Essential Components of Microbial Safety Testing

By Heather Ebling

Microbial contamination on cannabis products represents one of the most significant threats to cannabis consumers, particularly immunocompromised patients who are at risk of developing harmful and potentially fatal infections.

As a result, regulatory bodies in the United States and Canada mandate testing cannabis products for certain microbes. The two most popular methods for microbial safety testing in the cannabis industry are culture-based testing and quantitative polymerase chain reaction (qPCR).

When considering patient safety, labs should choose a method that provides an accurate account of what is living on the sample and can specifically target the most harmful microbes, regardless of the matrix.

1. The Method’s Results Must Accurately Reflect the Microbial Population on the Sample

The main objective of any microbial safety test is to give the operator an indication of the microbial population present on the sample.

Figure 1: MA data collected directly from plant material before and after culture on 3M petrifilm and culture-based platforms.

Culture-based methods measure contamination by observing how many organisms grow in a given medium. However, not all microbial organisms grow at the same rate. In some cases, certain organisms will out-compete others and as a result, the population in a post-culture environment is radically different than what was on the original sample.

One study analyzed fifteen medicinal cannabis samples using two commercially available culture-based methods. To enumerate and differentiate bacteria and fungi present before and after growth on culture-based media, all samples were further subjected to next-generation sequencing (NGS) and metagenomic analyses (MA). Figure 1 illustrates MA data collected directly from plant material before and after culture on 3M petrifilm and culture-based platforms.

The results demonstrate substantial shifts in bacterial and fungal growth after culturing on the 3M petrifilm and culture-based platforms. Thus, the final composition of microbes after culturing is markedly different from the starting sample. Most concerning is the frequent identification of bacterial species in systems designed for the exclusive quantification of yeast and mold, as quantified by elevated total aerobic count (TAC) Cq values after culture in the total yeast and mold (TYM) medium. The presence of bacterial colonies on TYM growth plates or cartridges may falsely increase the rejection rate of cannabis samples for fungal contamination. These observations call into question the specificity claims of these platforms.

The Live Dead Problem

Figure 2: The enzyme is instantaneously inactivated when lysis buffer is added

One of the common objections to using qPCR for microbial safety testing is the fact that the method does not distinguish between live and dead DNA. PCR primers and probes will amplify any DNA in the sample that matches the target sequence, regardless of viability. Critics claim that this can lead to false positives because DNA from non-viable organisms can inflate results. This is often called the Live-Dead problem. However, scientists have developed multiple solutions to this problem. Most recently, Medicinal Genomics developed the Grim Reefer Free DNA Removal Kit, which eliminates free DNA contained in a sample by simply adding an enzyme and buffer and incubating for 10 minutes. The enzyme is instantaneously inactivated when lysis buffer is added, which prevents the Grim Reefer Enzyme from eliminating DNA when the viable cells are lysed (see Figure 2).

2. Method Must Be Able to Detect Specific Harmful Species

Toxic Aspergillus spp., which is responsible for at least one confirmed death of a cannabis patient, grows poorly in culture mediums and is severely underreported by current culture-based platforms. And even when Aspergillus does grow in culture, there is a certain non-pathogenic Aspergillus species that look remarkably similar to their pathogenic cousins, making it difficult to speciate using visual identification alone.

Conversely, qPCR assays, such as the PathoSEEK, are designed to target DNA sequences that are unique to pathogenic Aspergillus species, and they can be run using standard qPCR instruments such as the Agilent AriaMx. The primers are so specific that a single DNA base difference in the sequence can determine whether binding occurs. This specificity reduces the frequency of false positives in pathogen detection, a frequent problem with culture-based cannabis testing methods.

Additionally, Medicinal Genomics has developed a multiplex assay that can detect the four pathogenic species of Aspergillus (A. flavus, A. fumigatus, A. niger, and A. terreus) in a single reaction.

3. The Method Must Work on Multiple Matrices

Figure 4: The team also placed TSB without any E. coli onto a petrifilm to serve as a control.

Marijuana infused products (MIPs) are a very diverse class of matrices that behave very differently than cannabis flowers. Gummy bears, chocolates, oils and tinctures all present different challenges to culture-based techniques as the sugars and carbohydrates can radically alter the carbon sources available for growth. To assess the impact of MIPs on colony-forming units per gram of sample (CFU/g) enumeration, The Medicinal Genomics team spiked a known amount of live E. coli into three different environments: tryptic soy broth (TSB), hemp oil and hard candy. The team then homogenized the samples, pipetted amounts from each onto 3M™ Petrifilm E. coli / Coliform Count (EC) Plates, and incubated for 96 hours. The team also placed TSB without any E. coli onto a petrifilm to serve as a control. Figures 3 and 4 show the results in 24-hour intervals.

Table 1: DNA was spiked into various MIPs

This implies the MIPs are interfering with the reporter assay on the films or that the MIPs are antiseptic in nature.

Many MIPs use citric acid as a flavoring ingredient which may interfere with 3M reporter chemistry. In contrast, the qPCR signal from the Agilent AriaMx was constant, implying there is microbial contamination present on the films, but the colony formation or reporting is inhibited.

Table 3: SenSATIVAx DNA extraction can successfully lyse the cells of the microbes

Table 2: Different numbers of DNA copies spiked into chocolate

This is not an issue with DNA-based methods, so long as the DNA extraction method has been validated on these matrices. For example, the SenSATIVAx DNA extraction method is efficient in different matrices, DNA was spiked into various MIPs as shown in Table 1, and at different numbers of DNA copies into chocolate (Table 2). The SenSATIVAx DNA extraction kit successfully captures the varying levels of DNA, and the PathoSEEK detection assay can successfully detect that range of DNA. Table 3 demonstrates that SenSATIVAx DNA extraction can successfully lyse the cells of the microbes that may be present on cannabis for a variety of organisms spiked onto cannabis flower samples.

October 21, 2019

Soapbox

Cannabis Growers and Distributors: Your Cyber Risk is Growing Like Weeds

By Emily Selck

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Cannabis growers and distributors are “green” when it comes to cyber security. Unaware of the real risks, cannabis businesses consistently fall short of instituting some of the most basic cybersecurity protections, leaving them increasingly vulnerable to a cyber-attack.

Cannabis businesses are especially attractive to hackers because of the vast amount of personally identifiable and protected health information they’re required to collect as well as the crop trade secrets they store. With businesses growing by leaps and bounds, and more and more Americans and Canadians purchasing cannabis, cybercriminals are likely to increase their attacks on the North American market in the coming year. Arm your cannabis business with the following best practices for growers and distributors.

Distributor Risk = A Customer’s PII

Cyber risk is the greatest for cannabis distributors, required to collect personal identifiable information (PII), including driver’s licenses, credit cards, medical history and insurance information from patients. State regulatory oversight further compounds the distributor’s risk of cyber-attack. If you’re a cannabis distributor, you’ll want to make sure to:

Know where you retain buyer information, and understand how it can potentially be breached. Are you scanning driver’s licenses into a database, or retaining paper files? Are you keeping them in a secure area off site, or on a protected network? Make sure a member of your management team is maintaining compliance with HIPAA and state statutes and requirements for cannabis distribution.
Institute strong employee oversight rules. Every employee does not have to have access to every sale, or your entire database of proprietary customer information. Delegate jobs behind the sales desk. Give each employee the access they need to do their job – and that’s it.
Distributors have to protect grower’s R&D information too. Most cannabis distributors have access to their grower’s proprietary R&D information so they can help customers understand which products are best for different medical symptoms/needs. Make sure your employees don’t reveal too much to put your suppliers in potential risk of cyberattack.

Grower Risk = Crop Trade Secrets

For cannabis growers, the risk is specific to crop trade secrets, research and development (R&D). If you’re a cannabis grower, you’ll want to:

Secure your R&D process. If you’ve created a cannabis formula that reduces anxiety or pain or boosts energy, these “recipes” are your competitive advantage – your intellectual property. Consider the way you store information behind the R&D of your cannabis crops. Do you store it on electronic file, or a computer desktop? What type of credentials do people need to access it? Other industries will use a third party cloud service to store their R&D information, but with cannabis businesses that’s typically not the case. Instead, many growers maintain their own servers because they feel this risk is so great, and because their business is growing so fast, there are not yet on the cloud.
Limit the number of people with access to your “secret sauce.” When workers are harvesting crop, or you’re renting land from farmers and planting on it, make sure to keep proprietary information in the hands of just the few who need it – and no one else. This is especially important when sharing details with third party vendors.

Cyber coverage is now ripe for picking

Although cannabis businesses are hard to insure – for just about every type of risk – cyber insurance options for cannabis companies have recently expanded, and come down in price. If you’ve looked for cyber coverage in the past and were previously unable to secure it, now is the time to revisit the market.

Know that cyber policy underwriters will do additional due diligence, going beyond the typical policy application, and ask about the types of proprietary information you collect from customers, as well as how you store and access it at a later date. Have this knowledge at your fingertips, and be ready to talk to underwriters about it when you’re bidding for a new policy – and at renewal time.

October 18, 2019

A Second Chance: CannTrust To Destroy Inventory & Plants

By Marguerite Arnold

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The beleaguered CannTrust has been given a way out of the perilous mess that executive management created for the company – but such a salvation comes at a high cost. That said, the company was already in deep water with regulators and clients. Health Canada, in fact, cancelled the company’s license to produce and sell cannabis in September – essentially mandating mass returns two months after a whistleblower instigated what is probably the legal industry’s most egregious scandal to date.

Efforts to regain regulatory approval also include plans by the company to recover cannabis that was not authorized by its license, and improve inventory tracking – the full details of which will be delivered to Health Canada by October 21.

While the beleaguered pot company’s stock predictably surged again on the public markets, the question lingers: can CannTrust ever be trusted again? These were egregious violations.

A Changing Industry

As with most things in business, the issues plaguing CannTrust were not isolated to one company. This has ranged in the past from pesticide use to creative accounting. Not to mention all sorts of creative endeavors on the financial side that are, depending on which stock market you look at this from, less than legit or just this side of shady.

It was easy to throw the book at a company like this – not only for these specific violations, but also as a warning to others tempted to engage in similar tactics (or fail to clean those up that still exist).

CannTrust in other words, was a clarion bell about the change in the weather, driven not only by international treaties but the legitimization of the drug, on the ground. Globally. When large health insurers get involved (see Europe), the conversation begins to change. And it is, fairly drastically.

On the ground in Germany, there are two more cultivation sites underway with one now certified and functional. BfArM (the German equivalent of the FDA) is now on the front lines of a battle that so far, at least in Canada, has not been addressed at a level Europe requires. That said, this reality too is changing. One of the largest distributors in Germany, CC Pharma, now owned by Aphria, has started a supply chain compliance check that is overdue. And further, while focussed on the cannabis industry, in truth, is a problem that plagues pharma far from cannabinoids.

However, as this is the cannabis industry, the scandals that rip through headlines are that much more visceral.

Seed to sale traceability, and further in a model unseen in the industry so far, will also become a watchword that is still rippling through an international industry chafing at any sort of standards, let alone standardization required for pharmaceutical acceptance. The bar, in other words, has just been set much higher. And there are many who will not make the grade.

CannTrust, certainly, was a victim not only of internal mismanagement, but a shifting environment that is rapidly upgrading on a level not seen so far in the entire North American industry – with a few notable exceptions.

Pharmaceutical Grade Is The Standard To Beat

Here is the reality now facing an industry coming into its own and on an international basis. The standards are tightening. The rules are not only being written but being enforced. And while there are sure to be a few more scandals along the way, the kinds of basic problems found at CannTrust are probably, finally, going extinct in the part of the industry that now knows it is being held accountable to far higher standards.

The reason? Medical grade and national food standards are in the room for every exporter now eyeing Europe. And that alone is resetting the debate everywhere. No matter how treacherous the path may be.

So no matter how harsh the penalties are now facing one company, even the regulators know that this is shifting territory. CannTrust, after all, is being given a second chance.

October 18, 2019

Safeguarding Your International Supply Chain: The Brave New World Of Cannabis Compliance

By Marguerite Arnold

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The CannTrust story may have shocked the uninitiated, but it hit almost every bogeyman the legitimizing industry has both feared and suffered from, particularly of late.

Here, generally, is the issue. Especially in Europe (even more especially in places like Germany, the UK and other emerging markets), budding cannapreneurs need each other. A distributor in Germany, for example, cannot get their final (federal) licenses allowing them to do business without establishing a relationship with an existing producer. That producer also needs relationships with established distributors to get their licenses.

In a fraught world, where all parties are evolving rapidly (and this also includes the “Big Boys” from Canada and several U.S. states including California), supply chain logistics, and even contract agreements if not licensing beyond that requires a level of honesty, integrity and transparency the industry, largely has not achieved yet.

That said, there are also parties, if not individuals and companies determined to set themselves on the straight and narrow – and play by the emerging “rules” – and then there are also clearly companies which, well, do not.

Being out of compliance, at any step of the chain, including when your product is sold via government agencies, is already a recipe for disaster.What this brave new world of cannabis requires, however, and from everyone – from grower, to manufacturer, packager, distributor and service delivery – is that all ecosystem partners must be in compliance.

Ensuring that can be a full time job. But what it also means is that to have a fully compliant product, every party in the chain bears responsibility for upholding standards that so far have proved hard to reach for many.

The time has come, in other words, where that is no longer an option.

The First Step Is Certification…

In a world where every member of the diverse cannabis ecosystem requires certification, determining what, and from whom is the first hurdle – both for buyer and seller. If one has GMP-certified product, that is awesome. But there are also treaties in the room that only allow some GMP certifications to be considered equal to others. If you are in Lesotho right now, for example, far from Europe, your biggest concern is not just looking to the EU but figuring out a way to export your crop into your neighbouring (and surrounding) country – namely South Africa.

This example, while seemingly far away, in fact, is the biggest bugbear in determining who can sell to whom even within Europe (let alone countries just outside and far beyond the region).

Determining cert presence, if not validity, however, is only the tip of the iceberg. And depending on who you are, that path alone is not a one time dalliance with authorities, but multiple certifications that must all also be kept current.

But It is Not The Only One…

The second hurdle, of course, is also checking the verity of everyone you do business with. For a producer, this includes making sure that processing, packaging, and even transportation are in compliance. In Canada, of course, this has been short circuited by the ability of producers to ship directly to patients.

In Europe, however, this is far from the case. And that is also why the entire conversation is also getting not only much more granular, but expensive. Pharmaceutical regulations are actually what guide the rules of the road here.

Walking floors, and checking, in person, may or not be mandated by international treaties at this point. However, most of the young producers on the ground here are implementing policies of personal visits to their vendors. In Massachusetts of late, this is also on the drawing board. Albeit on a “state” level, the reality is that both federal, state and more local training is a watchword, if not a must, now on the roadmap.

Being out of compliance, at any step of the chain, including when your product is sold via government agencies, is already a recipe for disaster.

And while that obviously is a challenge, companies must step up to the plate internally to commit to the same. It is too dangerous to ignore such steps. Including the easy to reach ones, like staff background checks and decent cybersecurity safeguards. The former has blown several enterprising cannadudes out of the driver’s seat already in Europe over the last few years. The latter is an emerging threat in a region that is also home to GDPR regulation (and growing fines).

For that very reason, certainly on the ground in Germany if not across Europe and in those countries and companies that wish to supply the same, supply chain verification, that is constant, consistent and verifiable, is the path for the industry both as of now and in the immediate future.

October 17, 2019

The Best Way to Remediate Moldy Cannabis is No Remediation at All

By Ingo Mueller

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Consumers are largely unaware that most commercial cannabis grown today undergoes some form of decontamination to treat the industry’s growing problem of mold, yeast and other microbial pathogens. As more cannabis brands fail regulatory testing for contaminants, businesses are increasingly turning to radiation, ozone gas, hydrogen peroxide or other damaging remediation methods to ensure compliance and avoid product recalls. It has made cannabis cultivation and extraction more challenging and more expensive than ever, not to mention inflaming the industry’s ongoing supply problem.

The problem is only going to get worse as states like Nevada and California are beginning to implement more regulations including even tougher microbial contamination limits. The technological and economic burdens are becoming too much for some cultivators, driving some of them out of business. It’s also putting an even greater strain on them to meet product demand.

It’s critical that the industry establishes new product standards to reassure consumers that the cannabis products they buy are safe. But it is even more critical that the industry look beyond traditional agricultural remediation methods to solve the microbial problems.

Compounding Risks

Mold and other microbial pathogens are found everywhere in the environment, including the air, food and water that people consume. While there is no consensus yet on the health consequences of consuming these contaminants through cannabis, risks are certainly emerging. According to a 2015 study by the Cannabis Safety Instituteⁱ, molds are generally harmless in the environment, but some may present a health threat when inhaled, particularly to immunocompromised individuals. Mycotoxins resulting from molds such as Aspergillus can cause illnesses such as allergic bronchopulmonary aspergillosis. Even when killed with treatment, the dead pathogens could trigger allergies or asthma.

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

There is an abundance of pathogens that can affect cannabis cultivation, but the most common types are Botrytis (bud rot, sometimes called gray mold) and Powdery Mildew. They are also among the most devastating blights to cannabis crops. Numerous chemical controls are available to help prevent or stem an outbreak, ranging from fungicides and horticultural oils to bicarbonates and biological controls. While these controls may save an otherwise doomed crop, they introduce their own potential health risks through the overexposure and consumption of chemical residues.

The issue is further compounded by the fact that the states in which cannabis is legal can’t agree on which microbial pathogens to test for, nor how to test. Colorado, for instance, requires only three pathogen tests (for salmonella, E. coli, and mycotoxins from mold), while Massachusetts has exceedingly strict testing regulations for clean products. Massachusetts-based testing lab, ProVerde Laboratories, reports that approximately 30% of the cannabis flowers it tests have some kind of mold or yeast contamination.

If a cannabis product fails required microbial testing and can’t be remedied in a compliant way, the grower will inevitably experience a severe – and potentially crippling – financial hit to a lost crop. Willow Industries, a microbial remediation company, says that cannabis microbial contamination is projected to be a $3 billion problem by 2020ⁱⁱ.

Remediation Falls Short
With the financial stakes so high, the cannabis industry has taken cues from the food industry and adopted a variety of ways to remediate cannabis harvests contaminated with pathogens. Ketch DeGabrielle of Qloris Consulting spent two years studying cannabis microbial remediation methods and summarized their pros and consⁱⁱⁱ.

He found that some common sterilization approaches like autoclaves, steam and dry heat are impractical for cannabis due the decarboxylation and harsh damage they inflict on the product. Some growers spray or immerse cannabis flowers in hydrogen peroxide, but the resulting moisture can actually cause more spores to germinate, while the chemical reduces the terpene content in the flowers.

Powdery mildew starts with white/grey spots seen on the upper leaves surface

The more favored, technologically advanced remediation approaches include ozone or similar gas treatment, which is relatively inexpensive and treats the entire plant. However, it’s difficult to gas products on a large scale, and gas results in terpene loss. Microwaves can kill pathogens effectively through cellular rupture, but can burn the product. Ionizing radiation kills microbial life by destroying their DNA, but the process can create carcinogenic chemical compounds and harmful free radicals. Radio frequency (which DeGabrielle considers the best method) effectively kills yeast and mold by oscillating the water in them, but it can result in moisture and terpene loss.

The bottom line: no remediation method is perfect. Prevention of microbial contamination is a better approach. But all three conventional approaches to cannabis cultivation – outdoors, greenhouses and indoor grow operations – make it extremely difficult to control contamination. Mold spores can easily gain a foothold both indoors and out through air, water, food and human contact, quickly spreading into an epidemic.

The industry needs to establish new quality standards for product purity and employ new growing practices to meet them. Advanced technologies can help create near perfect growing ecosystems and microclimates for growing cannabis free of mold contamination. Internet of Things sensors combined with AI-driven robotics and automation can dramatically reduce human intervention in the growing process, along with human-induced contamination. Natural sunlight supplemented with new lighting technologies that provide near full-light and UV spectrum can stimulate robust growth more resistant to disease. Computational fluid dynamic models can help growers achieve optimal temperature, humidity, velocity, filtration and sanitation of air flow. And tissue culture micropropagation of plant stock can eliminate virus and pathogen threats, to name just a few of the latest innovations.

Growing legal cannabis today is a risky business that can cost growers millions of dollars if pathogens contaminate a crop. Remediation methods to remove microbial contamination may work to varying degrees, but they introduce another set of problems that can impact consumer health and comprise product quality.

References

i. Holmes M, Vyas JM, Steinbach W, McPartland J. 2015. Microbiological Safety Testing of Cannabis. Cannabis Safety Institute. http://cannabissafetyinstitute.org/wp-content/uploads/2015/06/Microbiological-Safety-Testing-of-Cannabis.pdf

ii. Jill Ellsworth, June 2019, Eliminating Microbials in Marijuana, Willow Industries, https://willowindustries.com/eliminating-microbials-in-marijuana/#

iii. Ketch DeGabrielle, April 2018, Largest U.S. Cannabis Farm Shares Two Years of Mold Remediation Research, Analytical Cannabis, https://www.analyticalcannabis.com/articles/largest-us-cannabis-farm-shares-two-years-of-mold-remediation-research-299842

October 17, 2019

A Regulatory Tsunami is Washing Over the Canadian Cannabis Industry

By Steven Burton

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On August 29, 2019, Health Canada finally published a guidance document on the official interpretation of Part 5 of the Cannabis Regulations concerning “Good Production Practices” that comes into force just seven weeks later on October 17, 2019. For those watching with the experience of the food industry, it is safe to say that few license holders fully appreciate the magnitude of the new requirements and fewer yet are prepared for what will be required in less than two weeks.

An Uncertain Road to Cannabis Compliance

Since Canada legalized recreational cannabis in October 2018, there has been considerable uncertainty about the road to compliance in this totally new legal market. Health Canada faced the daunting challenge of defining the requirements for a whole new industry, and so they were understandably silent on the issue of Part 5 until this guide was published in August.

Many larger companies eager to get their foot in the door of the multi-billion dollar industry tried to be proactive in anticipating impending government regulations by seeking Good Manufacturing Practices (GMP) certifications. This would likely have been fine under the previous regulations, which were myopically focused on ensuring that product wasn’t diverted from or to the black market. With the legalization of edibles only one year away, however, it was obvious to those in the food industry that GMP was just not going to be enough. Gentle prodding at various speaking engagements on our part wasn’t enough to convince these companies to seek higher levels of certification or at least to proactively develop the organizational culture required to support a higher-level program.

The Inevitable Necessity of Food Safety

It was clear to us that since edibles are essentially a food product, safety necessarily had to become a primary focus. This reality has, in fact, materialized in section 5 of the new guide, which outlines prescriptive requirements that are very well developed and require that companies develop a complete set of Standard Operating Procedures (SOPs) for sanitation, employee hygiene, testing, inventory, pest control and more. Furthermore, cannabis companies must be able to produce documentation that proves they are actually following these procedures.

There are many, many other requirements that also apply, but the really interesting ones are those related to hazard analysis (5.2.13) and preventive control plans (5.2.14): manufacturers who produce extracts or edibles must undertake hazard analyses on each input, processing step and traffic flow. The language will be familiar to those who have been exposed to Hazard Analysis and Critical Control Point (HACCP) methodology. HACCP is the standard in the food industry and goes far beyond simple GMP.

Very much like HACCP, license holders will be required to analyze each biological, chemical and physical hazard, determine controls, identify critical control point, along will all the validation, reassessment, verification and deviation protocols required. Interestingly, the fraud and bioterrorism hazard types that have recently been introduced for the food industry have been omitted, presumably an oversight that will be rectified in future versions.

How to Catch Up Fast with Tech

Satisfying these regulations using traditional manual methods takes months or even years in some cases. Today in Canada, license holders have only weeks to get their facilities to compliance, and the government is quick to crack down on any mistakes. The only way to possibly meet this deadline is to start yesterday and use the best tools you can find to expedite the process.

Those who have been busy implementing GMP programs are going to have to look far beyond their current objectives. Those just starting out should build with these requirements front of mind, both to satisfy inspectors and auditors and also to avoid the pain of the organizational change required to move to a higher level of quality and safety.

Ultimately, these changes will be of benefit to society and provide a competitive advantage to those who can move the fastest, especially when major retail chains become the dominant wholesale market. My advice is to start working on your HACCP-based compliance program immediately and, if you’re in Canada, seek a high-level certification like SQF as soon as possible.

It’s fair to say that the food industry’s recent experiences with more stringent regulations clearly foreshadow what will be required for the cannabis industry. Right now – when the margin of error is razor thin – is the time for companies to make the decisive move and focus on their success – and survival.

October 15, 2019

Soapbox

Searching for the Good Stuff

By Cindy Rice

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Someone approached me the other day, wanting to know what was the real story about hemp and CBD.

He said he had “a guy” who gave him a CBD salve as part of a study, supposedly “the good stuff,” to help his knee. He couldn’t understand why he was the only one out of 20 people in the group that felt no relief. He happened to have this CBD salve with him, along with a second brand that he hadn’t yet tried. The “good stuff” had slick, colorful packaging, a beautiful logo and powerful marketing messages about the phytocannabinoids and essential oils in the jar. The other CBD product was in a dull grey tin, an ugly duckling, and not nearly so impressive on the outside- I’ll call it “Homer’s Brew.” My friend dismissed Homer’s Brew outright, as not even worth trying. I told him that not all CBD products are created equal, that you can’t always believe the claims on the package, including the cannabinoid potency displayed on the label.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

I told him to search for the Certificate of Analysis (COA) for each of the two products, specifically, lab test results validating the CBD dosage per serving, and also the breakdown of pesticides, heavy metals and microbials. He had to do a little digging and emailing, as it wasn’t readily available for either company, but the next day, results were in. The “good stuff” with the slick packaging and bold claims had mere trace amounts of CBD, with some hemp and essential oils- no tests for pesticides or contaminants of any kind. Hmmm, no wonder he was disappointed. Homer’s Brew’s COA came in with flying colors – a reputable lab had confirmed safe levels of pesticides, pathogens and heavy metals, and the CBD level was substantial, with a detailed cannabinoid breakdown in the lab report.

In spite of the varying legality of hemp-derived CBD products from one state to the next, consumers are gobbling up costly CBD salves, tinctures and edibles in markets, gyms and online. Like moths to a flame, they are pulled in by the CBD name and lofty promises, not always understanding what they are getting for their money. They trust that these products are safe, licensed, inspected and regulated by some agency, otherwise, “they wouldn’t be on the shelves, would they?”

In spite of the 2018 Farm Bill, FDA still has not recognized the legality of products containing hemp-derived CBD, but some states have gone ahead and given them a green light anyway- check with your own jurisdiction to be sure. In the meantime, hemp-derived CBD products are slipping through the regulatory cracks, depending on the state. It is confusing, for sure, and buyer beware.

Separate yourself from the pack of snake-oil salesmen. Test your products for safety and accurate cannabinoid potency, and make a Certificate of Analysis readily available to your customers. Boldly portray your transparency and belief in the quality of your products through this COA.

Providing this information to consumers is the best path to success- safe, satisfied customers who will refer to their friends and family, and most likely come back for more of your “good stuff.”

October 15, 2019

Massachusetts Implements Responsible Vendor Training Program

By Aaron G. Biros

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According to a press release published earlier this week, the Massachusetts Cannabis Control Commission approved Cannabis Trainers as one of the state’s first vendor training providers. The training program, Sell-SMaRT™ is the world’s first state-approved cannabis vendor training.

Regulations in Massachusetts require all licensed growers, managers and employees that handle cannabis to take a responsible vendor training class through a certified provider by January 1, 2020.

The Sell-SMaRT™ program was originally developed for licensees handling cannabis in Colorado. In 2015, Colorado regulators granted the program the first ever certification for its Responsible Vendor Program in cannabis. Since then, almost 4,000 people have taken the Cannabis Trainers class, which has been customized for six states, including Massachusetts.

Maureen McNamara, founder of Cannabis Trainers, built on two decades of experience in alcohol vendor training before she started the training program for cannabis. “Massachusetts is really setting a new standard with its training requirements,” says McNamara. “We’ve worked hard to customize the Sell-SMaRT™ program for the state’s needs, and we appreciate the Cannabis Control Commission’s recognition of that. We’re excited to help inspire a cannabis workforce in the state that is responsible, compliant and committed to excellence.”

Meg Sanders, CEO of Canna Provisions, a Massachusetts cannabis company, says the program helps her employees learn the rules thoroughly. “Cannabis Trainers trained all of my Colorado employees, and my entire team in Massachusetts as well,” says Sanders. “I know every time Cannabis Trainers meets with my staff, we walk away smarter and better prepared to help our customers.”

October 14, 2019

CBD In The UK: An Unregulated Marketplace

By Marguerite Arnold

3 Comments

You have to give it to this industry. Everyone wants in. And well, Prohibition is so over.

The problem is, particularly here in Europe, for the most part, this is either the tedious process of educating doctors, creating medical grade product that insurers will pay for, or of course, trials to look forward to in the immediate future.

In other words, decidedly less colorful (or at least in the North American sense) if not at lower volume than other places.

In the meantime, particularly filtered via American and Canadian coverage and industry success stories, the British are succumbing to the green magic any way they can.

Low-THC, CBD products as a result, are flourishing in a way that seems a bit like the “Colorado of Europe.” The early days. When all sorts of strange stories about processing leaked out of the first legalizing state market in the U.S. It is shocking to European eyes, in particular, of late.

“CBD” is, literally, everywhere.

For those with other kinds of experience in the world of cannabis, however, it is both slightly sad and slightly exhilarating. The Brits have the cannabis bug. But they seem a bit lost on where to go next.

What Is The Deal In The UK?

Regulations are weird here. You cannot use the flower of any cannabis flower (including those with under the requisite amount of THC) – also known as hemp. The novel food discussion is lost.

Regardless, there are clearly plans afoot, particularly on the corporate farming level, to begin a transformation of crops to include cannabis sometime soon. And far beyond the farmers, the boys in the city are getting hot under the collar for this kind of green.

London is also turning into (rather predictably) a center of all things cannabis equity.

There are already more specialty funds planning to list on London exchanges than anywhere else in Europe.

But is this all that surprising?

In the midst of Brexit, a failing NHS, and a society at odds with itself like no time since the 1970’s, the British are facing the cannabis revolution with anything but a stiff upper lip.

When it comes to all things cannabinoids, at least on the CBD side, no matter the odd police raid on a health food store or crunchy vegan experiment on land not protected by the rights of an inherited “country pile”, the cannabis horse, certainly of the broadly stroked CBD variety, is out of the barn.

But What Does this Really Mean?

For the moment? As globally financed companies set up in the UK for all kinds of cannabis trials, the CBD market here is taking on an oddly Bulldog twist.

There is more of a cottage industry of all kinds of CBD products unseen elsewhere in Europe (including from the U.S.). Labeling, testing and sourcing are largely a matter of hit or miss. And just like everywhere else, desperate, sick, depressed people (or those who fear becoming that way) are turning to the CBD miracle to fix a range of conditions.

The problem is that a lot of this is pure snake oil.

Yes, high quality, medical grade CBD does work as a stabilizer (just like THC). But not every oil containing some measure of highly diluted (or worse, contaminated) cannabinoid extract, is the panacea that cannabis offers.

Bottom line? The CBD market in the UK is sort of like Swiss Lite. There are medical trials in the offing, but the country is also in the middle of a constitutional crisis. There are many regulations, and of a bit more fundamentally intrinsic kind, on the line right now. Cannabis is in the room. But so is the Irish Border (the largest if not most existential sticking point in the never-ending Brexit negotiations).

Investing In The UK CBD Market

There are investors who are clearly examining the market, and a few big deals so far, but the vast majority of money flowing into the UK is going into its more flexible (if not frothy) equity market. The British, in other words, may be flailing a bit on domestic implementation, but equity funds in London are in touch with global investors on this issue – even if that money then flows back into Europe.

How very British.

October 11, 2019

What Does GMP Mean? And How Is This Different From EU-GMP?

By Marguerite Arnold

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The cannabis industry is on the road to legitimacy, no matter the bumps, globally. No matter what, and no matter what happens next, that is a good thing. Issues like supply chain transparency, privacy, consumer and patient safety, and of course energy and water use have long been in the room just about everywhere.

Cleantech Is Cannatech

The modern cannabis industry was birthed and given significant shape in deserts (Israel, California, Nevada). In California, as of 2014, producers were warned, yet again, that they could not avail themselves of federally overseen aquifers of groundwater. The legitimizing industry trucked in what it needed.

On the medical discussion, in Europe, in particular, such issues are now in the room. All medical cannabis must be grown indoors. No exceptions.

That means low energy, high efficiency production is on the rise, not the wane.

What Does GMP Mean?

The overall regulations and operating procedures that surround this discussion are known as “Good Manufacturing Practices,” or GMPs for short. But like all the best acronyms, what the standards are, who sets them, and where they are equivalent is still a shifting picture.

Further, GMPs, and even more particularly EU-GMPs, are specifically referred to this way to distinguish the medically bound product from other consumer protection regulations that include novel food.

That said, “GMP practices” differ widely from industry to industry. The idea behind them, however is to prevent harm from occurring to the user, including that the end product is free from contamination, and the packaging as well as manufacture has been well documented. Additional requirements include that personnel are properly trained.

And while the practice, at the pointed end of enforcement can get nerdy, detail-oriented and specific, that is precisely the point. That is also why you might catch another variant of this acronym (cGMP – or current GMP guidelines), to denote a world that is changing fast.

Contamination of the supply chain if not the carbon impact of the same, for all food and plant-based pharmaceutical products is a 21st century problem that is exploding on the scene as fast as the planet warms and cannabis legalizes.

What Do GMP Guidelines Include?

These are guidelines, not steps. As a result, from a bird’s eye view, all international and sovereign national GMP standards include a few basic principles no matter how much they may differ in the weeds. Namely:

That manufacturing processes are clean, controlled and processes are verifiable and repeatable. Changes to any and all must also be clearly documented.
Record keeping, accurate accounting (of product and on the financial side) must be kept, including complete batch history through manufacture and distribution to the end user. Audits are a way of life.
Recall procedures must be in effect.
All complaints about products must be examined.

The World Health Organization (WHO) version of GMP is what’s used by pharmaceutical regulators worldwide. The European Union’s EU-GMP standards are seen as roughly equivalent, as are those now practiced in the U.S. by the FDA. That does not mean that confusion does not reign as standards are changing (across Europe, for example, between individual countries, there is still disagreement). However similar GMPs are used in countries including Australia, Canada, Japan, and Singapore. The UK, of course, is slightly different than anyone else but still has regulations that are roughly equivalent and referred to as “The Orange Guide” (in honor of the color of the book’s cover).

You Know It When You See It

Well, not quite. Beyond GMP, there are of course, other classifications for the kind of plant or product being made, manufactured and distributed. And here, along with international treaties about who can trade with whom, also impact this discussion.

It is not correct, however, for example, to claim that what are known as GACP guidelines (good agricultural and collection practices) are equivalent to GMP. Bio, or pesticide free production (in other words) is just one of many steps in meeting much higher standards now in the room for medically bound cannabis.

What Is GMP “Like”?

All industries have “best practices.” For example, the building industry has all sorts of codes and guidelines. However, in addition to this, about a decade ago, LEED (or green building) certification began to be implemented widely. In the U.S., in particular, there was much discussion about how honest such certifications actually were. The term “greenwashing” was frequently used to describe practices that were sold as energy efficient, but in the end cost more, environmentally and otherwise, than they should.

Like LEED, GMP is not a prescribed set of steps but rather best practice guidelines and regulations meant to guide industries on producing safe products – from seed to sale.

How Does This Differ From WHO Guidelines on GACP for Medicinal Plants?

The World Health Organization’s GACP guidelines are highly controversial in this context, especially when it comes to cannabis. Especially because they refer specifically to plants used as medicine that are “grown in the wild.” I.e. not greenhouse. How these guidelines are interpreted by different countries, however, within the context of the interpretation of “medical cannabis” not to mention pharmaceutical GMPs, are very different.

GACP guidelines, in other words, are sometimes the first step in qualification – but certification under the same (starting with outdoor grown crops produced without pesticides for example) is not likely to pass European medical standards any time soon.