Tag Archives: medicine

Canadian Companies Continue European Cannabis Moves

By Marguerite Arnold
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There is a lot of European news afoot from the big public Canadian companies between all the headlines about Israel. Namely, established cannabis companies in the market already continue to shore up their presence across multiple member EU states.

What is at stake? Establishing some kind of European foothold in an environment where licensing and production costs will not bust the bank- and what will be the first government-set, pre-negotiated bulk price for medical cannabis flower. For all the high-flying news of even hundred million-dollar (or euro) investments, right now the biggest hunt is on for ways to trigger sales figures that continue to grow steadily in the customer column.

There is also a dawning realization that prices are going to start stabilizing if not falling after the German government finalizes its selection of bid winners.european union states

As a result of all of this, to compete against each other and streamline distribution and supply chain costs, the larger Canadian companies in the market are clearly angling to set up efficient distribution networks- even if that means buying pieces of them one country and property at a time.

How well that will work in the longer run remains to be seen- but it is a play that is starting to show up in other European developments (from the Israeli side). That said, the latest news of the big guys in the field make sense within this context, if none other.

Canopy Growth Announces UK and Polish Moves

Spectrum Cannabis, the European-based medical brand of Canopy Growth chalked two more achievements off its Euro “to do list” in January. At the beginning of the month, Spectrum announced it was preparing to enter the UK market via the creation of a joint venture with Beckley Canopy Foundation, Spectrum Biomedical.

In Poland, the company also announced the successful shipment of its high-THC whole flower “Red No.2.” The Polish government began allowing sales late last year.

Neither development however should be a surprise to those watching the strategy of either Canopy or for that matter several other public Canadian cannabis companies. Aurora, for example, announced its first successful shipment into the country on the same day that the Polish government changed the law. On the British side, the combined forces of changing the regulatory scheduling of cannabis and allowing the drug to be dispensed by prescription have certainly changed the game on some levels. Brexit is about to play havoc with most imported products, and cannabis is no exception to this.Canopy_Growth_Corporation_logo

In this sense, the challenges facing both British and Polish patients right now are also fairly analogous. Importing is the only way to get the drug to patients, and the cost of import is also prohibitively high for most. Then of course, there is actual approval beyond that, which is also a problem everywhere cannabis has become legal.

While both developments of course, are good news for the company, this does not mean that the initial going will be easy or smooth for any company, including one as skilled at strategic market entry in core countries across the continent for the last several years as Spectrum has reliably proven to be.

Green Organic Dutchman Gets Cultivation License In Denmark

TGOD has now gone where other Canadian Euro cannabis players have gone before– namely it has joined the national trial program and several other Canadian cannabis companies before it (see Spectrum Cannabis for one) in Denmark.

Why are so many public cannabis companies attracted to the tiny country? The first is that the country, like Switzerland, in fact, is not as bound by EU rules as say, Germany and France. It can “experiment” in ways that are notably different from its neighbors.

As a result of this and a change in the law that began a multiyear trial to experiment with regulation and medical efficacy, cultivation licenses are also easier to obtain than in other places. There are also other plusses to establishing a presence in the country if not the continent including a strong social care system, and a research environment that promises to produce great results on the medical efficacy discussion continent wide.

Liberty Health Sciences Receives Second GMP Certification

By Aaron G. Biros
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According to a press release sent out last week, Liberty Health Sciences announced that the British Standards Institution (BSI) awarded the Good Manufacturing Practices (GMP) certification for a facility located in Gainesville, Florida. The certification covers their 10,000 square foot medical cannabis manufacturing facility, where much of their extraction and processing takes place. Liberty also operates a large cultivation space at the same campus.

“it demonstrates our commitment to producing the highest quality and safest products possible for our customers throughout the state of Florida”According to Jessica Engle, director of regulatory compliance for Liberty, they actually did much more than just a GMP certification, including designing a HACCP plan. “In addition to GMP compliance, Liberty has gone above and beyond the DOH requirements to create a fully operational HACCP (Hazard Analysis Critical Control Point) plan that helps ensure the products we produce are safe for consumers,” says Engle. “The basis for HACCP is a scientific approach to preventative risk analysis. Every time a process changes, equipment changes, or raw material changes, our HACCP team meets to identify potential physical, chemical, and microbiological risks. Preventative measures are then put into place to help reduce the likelihood of the contamination hazard from ever occurring.”

Florida’s regulations on medical cannabis producers and processors actually require a form of certification demonstrating proper food safety protocols. “Within 12 months after licensure, a medical marijuana treatment center must demonstrate to the department that all of its processing facilities have passed a Food Safety Good Manufacturing Practices, such as Global Food Safety Initiative or equivalent, inspection by a nationally accredited certifying body,” reads Rule 9 in the 2017 Florida Statute. Edibles producers in Florida “must hold a permit to operate as a food establishment pursuant to chapter 500, the Florida Food Safety Act, and must comply with all the requirements for food establishments pursuant to chapter 500 and any rules adopted thereunder.” The rules also lay out requirements for packaging, dosage and sanitation rules for storage, display and dispensing of edible products.

Also according to the press release, the company is expecting to grow immensely, saying they will add an additional 160,000 square feet of cultivation space at their Gainesville campus. George Scorsis, CEO of Liberty Health Sciences, says this GMP certification is an important landmark for them. “Receiving GMP certification at an additional facility is a major milestone for Liberty Health Sciences and it demonstrates our commitment to producing the highest quality and safest products possible for our customers throughout the state of Florida,” says Scorsis. “This achievement reflects the incredibly high standards we expect of ourselves and that our clients expect as a patient provider. We will continue to produce the highest quality products and exceed production standards that surpass even the most stringent regulatory requirements.”

Liberty has dispensaries, manufacturing facilities and cannabis education centers all over Florida. They have plans to launch a large number of locations in 2019, including ones in Boca Raton, Ft. Myers, Miami, Orlando and more.

Beleave Achieves ISO 9001 Certification

By Aaron G. Biros
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According to a press release, Beleave Inc. announced recently that their subsidiary, Beleave Kannabis Corporation, received the ISO 9001:2015 certification. The facility that received the certification, based in Hamilton, Ontario, was certified “for the research, development, and production of cannabis products for medicinal and recreational purposes,” reads the press release.

Beleave is a vertically-integrated cannabis business headquartered in Oakville, Ontario that cultivates cannabis as well as producing oils and extracts. The company operates in both medical and recreational sectors of the market. They have been working on developing cannabis food and beverage products, such as infused powders and sugars, expecting that the recreational cannabis market in Canada will soon open its doors to infused products in 2019.

ISO 9001:2015 is an international standard that stipulates requirements for a quality management system (QMS), showing that a facility can provide products that meet customer and regulatory requirements. ISO 9001:2015 is the most up-to-date version for the standard, which can help show a company’s commitment to quality, efficiency and consistency. The 2015 version uses criteria with an emphasis on risk-based thinking to aid in the application of the process approach, improved applicability for services and increased leadership requirements.

“We continue to develop international partnerships and plan to enter global markets”The company’s facility was certified by Bureau Veritas Certification Holding SAS in late January of 2019. According to Roger Ferreira, chief science officer at Beleave, the process of certification was no easy undertaking. “After many months of hard work and preparation, we are extremely proud to be one of the few licensed producers of cannabis to have received ISO 9001:2015 accreditation,” says Ferreira. “This certification reflects Beleave’s ongoing commitment to quality across key elements of our business, which includes research, innovation, and production of cannabis products.”

Going beyond Canada, Ferreira says they are building the foundation of a company preparing to expand internationally. “Further, this internationally recognized certification for our quality management system positions us well as we continue to develop international partnerships and plan to enter global markets,” says Ferreira. Through their ownership in Procannmed S.A.S., they are licensed to cultivate and produce medical cannabis products out of Colombia, with the goal to export products to the Latin American market. They have also partnered with Canymed GmbH, based in Germany, to further explore opportunities in the European medical cannabis market.

8 Mistakes Businesses Make When Managing Product Labels: Part 1

By Rob Freeman
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Editor’s Note: This article contains the first four common labeling mistakes that businesses can make. Click here to view the next four common labeling mistakes. 

Whether you’re a small business owner or a production manager of a large manufacturer, if you’ve ever experienced problems with your product labels you know it can quickly turn into a serious issue until that problem is resolved. From the time it’s applied to your product all the way to the POS (Point of Sale), labels always seem to be the least significant part of the production process- until something goes wrong. And when it does go wrong, it can create major branding issues and cost your company tens of thousands of dollars due to hefty supply chain late penalties and/or even government fines.

This article aims to provide insight as to how a company like Label Solutions Inc. helps businesses and manufacturers create new labels for their products as well as what to look for should you experience label failure at your retail locations. Topics discussed in this article do not cover all possible issues, but these common mistakes will hopefully help you better understand how creating a product label works, and how to possibly prevent your own problems in the future.

Mistake #1: Not Understanding the Importance Between the “Construction” Versus the “Artwork & Compliance” of the Label

This may seem like common sense, but it is often overlooked. Especially when dealing with fast-track projects.

Construction of the Label is the material selected and production process to produce the label. When creating a new label from the ground up, it is important to factor in how your product will be produced, necessary shipping and supply chain needs, how it is stored in inventory and how it will be presented at the POS. Understanding what environments your product will be exposed to throughout its life cycle will give you an advantage when approving substrate material, inks, and the strength of adhesive that might be necessary for your application.

The Artwork & Compliance of the Label refers to the overall design of the label, artwork, customer messaging, bar codes and regulatory requirements you need to follow in order to avoid serious government fines that might relate to your industry (Referring to agencies such as OSHA, DOT, and the FDA).In most cases the construction of the label does not apply to the compliance of the label.

Most label providers do not have the in-house expertise to offer compliance assistance. Although it is still the manufacturer who is liable for all final artwork approvals on their product, label providers that do offer advisory services can help update label content when regulatory changes are enacted. This “safety net” can save your company from extra production costs and, potentially, excessive legal time and material costs. In short, you should always review final label artwork approvals with your compliance team and/or legal expert, but it never hurts to have a “safety net” to help eliminate unnecessary orders or production delays.

In most cases the construction of the label does not apply to the compliance of the label. An exception to this statement would be industries such as the electronics industry that use UL (Underwriter Laboratories) labels that must meet UL specifications and be produced under recognized UL files. In other words, the compliance of a UL label is the construction of the label.

Best Method Approach: An excellent example of companies that understand the difference between the Construction vs. Artwork & Compliance of the label would be the compressed gas industry. Gas suppliers and distributors require long term regulatory compliant labels on their cylinders and micro-bulk tanks. These gas tanks are used in a wide variety of industries such as for manufacturing, welding, medical procedures, and specialty gas mixes for the micro-electronics industry.

The compressed gas industry requires that their labels follow strict, up-to-date OHSA and DOT compliance requirements. As for the construction of the label, it is common practice that the label remains legible on the cylinder for an average of five years. The 5-year duration is due to the millions of tanks that are in circulation throughout the US and Canada. What’s more, each label is produced to adhere to the cylinder’s metal surface during extreme outdoor weather conditions such as fluctuating temperatures, freezing rain, high winds, and direct sunlight year-round.

Mistake #2: Applying Labels Incorrectly to Your Products

Whether the label is applied to the product surface by hand or automatically with a label applicator, the label itself may not be applied level or evenly. Besides this being a major branding issue, this could also affect how the bar codes are scanned and could eventually impact your delivery times while trying to correct a batch.

Best Method Approach: There are construction alternatives that you can choose from to potentially reduce the impact of incorrect label application. For example, products with certain label adhesives allow your production team to reposition the label within a few minutes before the tack completely sets to the surface. The type of surface (cardboard, metal, plastic, glass, etc.) and the type of adhesive will determine how much time your production team will have before the tack sets.

The best practice is to apply labels prior to filling the bottles and cans as opposed to filling first and then applying the label in your production line.A good example of this best practice can be seen in the beverage market. Whether the client produces a uniquely crafted beer, or a rare ingredient infused into a new health drink, labels that are auto-applied to bottles and cans will sometimes experience equipment tension issues that need to be recalibrated. Once labels are applied off-alignment, a delayed tack setting can allow the label to be quickly repositioned by hand when needed. The best practice is to apply labels prior to filling the bottles and cans as opposed to filling first and then applying the label in your production line. The reason, excess spillage from filling can interfere with most adhesives.

This same repositionable adhesive is excellent to keep in mind for large equipment production assembly lines that apply prime (branding) labels and warning labels by hand. Even with large wide-format labels, the adhesive tack can be formulated so your employees have a few minutes to adjust, straighten, and smooth away trapped air bubbles once it has been placed on the surface. Knowing you have this option can help reduce label inventory waste, additional production material wastes and avoid delaying production time. More importantly, this option keeps your brand and your warning/instructional labels looking fresh.

Mistake #3: Not Sharing Your Production Run Schedules with Your Label ProviderSupply chain management (SCM) models are excellent examples of the best approach.

Some of Label Solutions’ largest accounts have the most efficient real-time tracking supply chain models in North America, but even they cannot avoid sudden increased orders for their products stemming from high customer demand or similar issues. It is a good problem to have, but it is a problem, nonetheless. Manufacturers utilize supply chain management tools to notify their suppliers of their monthly order forecasts, which in turn helps suppliers manage their materials and deliveries more efficiently.

On the other side of the spectrum, when small businesses share their production schedules with a supplier it means that both parties (the manufacturer and label provider) understand when to expect higher or lower order quantities each month. Label providers should back date their label production schedules, so they have the materials available to handle your busier months while ensuring on-time deliveries.

Best Method Approach: Supply chain management (SCM) models are excellent examples of the best approach. Although SCM’s are designed for scalability and real-time tracking, the benefit to you also helps your label supplier. For example, our large retail and industrial manufacturing clients notify the Label Solutions team to produce their labels according to their Supply Chain portal demand schedules. This, in turn, allows label suppliers to allocate production time and materials more efficiently for your last-minute rush orders.

Smaller companies can take a much more simplified approach (without the SCM tracking) to help their suppliers manage their orders – even if they do not use supply chain management. A simple Excel report of production runs over a 12-month time frame is ideal. If your label provider does not already practice this or similar methodology, it might be time to start looking for a more proactive label provider. If you’re unsure you want to share your information, then you might consider requiring your label provider to sign an NDA (Non-disclosure Agreement).

Mistake #4: Not Accepting Alternative Sizes of the Label to Allow for Better Pricing

If your product needs a label with, for example, a dimension of 5.25 X 6.75 inches, there might be a much better price point offered to you if you’re open to switching to a slightly different dimension label of, say, 5 X 7 inches.  Obviously, you need to make sure the new dimension would fit your product(s) and work with your production line. But, if alternate dimensions are within the scope of the project, a modified SKU could potentially cut down on cost and production time.

Best Method Approach: You might not have the time or ability to change your label if you already market that product in retail stores. But, if you are changing your branding, creating a new style of label, or releasing a completely new product, this is the ideal time to consider implementing better continuity between your products. This could include elements such as matching colors and label/packaging design.

In addition to updating your SKU’s, this might also be an opportunity for your company to consolidate multiple products onto a universal label size. By applying the same sized labels to multiple SKU’s, you can increase efficiency regarding repeated label orders, especially for label printers that use digital printers. Combine this approach with your expected annual quantity estimates and you’ll be positioned for very efficient ordering options as your company grows.

Editor’s Note: We’ll cover the next four most common labeling mistakes in Part Two coming next week. Stay tuned for more!

israel flag

Here Comes The Start-Up Nation Of Cannabis: Israel

By Marguerite Arnold
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israel flag

For those who have been watching (if not in the thick of) the drama over Israeli medical cannabis export rights, this latest development was not only inevitable but overdue. Israel’s parliament unanimously approved the legislation on Christmas Day (along with Thailand). Less than a month later, the cabinet concurred.

That means that export rights are now actionable law.

Beyond this final passage into reality, export rights have been at the forefront of a global drama on cannabis- most recently in this part of the world, as a specific chip in political dealmaking between U.S. President and Israel’s Prime Minister, Benjamin Netanyahu since the former entered office. This go around at least.

Tel Aviv, Israel

The political bargaining that even allowed Israel’s medical program to flourish and get funding from its earliest days (including of the U.S. federal government kind) of course, is nothing new.

Pioneers Of The Cannabis Industry

Hard as it is to believe, most of what is widely known and easily digitally shared (including on social media) about cannabis (as a plant, let alone distinctions between cannabinoids) is information created during this last four to eight-year period (certainly since 2010). This has been driven by reform, and a birth of wider education about medical and recreational cannabis plus the cannabis industry and broader lifestyle press. And most of what is credible out there, no matter who claims credit today, has an Israeli origin, and of the medical kind.

Add this history of scientific research and insight to the philosophy of a nation driven by entrepreneurial zest, and say no more.

Now that Israel can begin to export its cannabis, the interesting thing to see is whether cannatech will in the end, be more valuable than individual strains themselves. The pick axe in this particular “green gold rush?”

For now, of course, all bets are off, even on the cultivation front. Because, no matter what else it is, it is well timed, globally, to give even the Israeli medical production market a big green shot in the arm.

Germany and Europe Beckons

The change in the law in Israel also comes as those who made first qualifying round in the German cultivation bid are getting prequalification letters, although this time, no firms, anywhere, have issued press releases about their finalist round status.

And here is the other issue to consider: While the bid itself does not have anything to do with import capability, new Israeli game in town is, in itself, a big game changer for anyone whose hat was thrown into the coalitions who applied for the pending cultivation license. Why? Until they deliver their first crops grown auf Deutschland, firms have to deliver from somewhere. And this being Germany, the import destination has to be from a place where the plant is federally legal. Israel becomes another option in a market so far dominated by Dutch and Canadian firms.

cannabis close up
The Tikun Olam strain Avidekel being grown in Israel.

Can you smell new bid lawsuits also, if this scenario has not already been addressed by BfArM? The history of cannabinoids in Germany in general (historically as well as recently) is fraught already. This pending challenge, should it come, will be laden with symbology modern Germany will do everything to avoid provoking.

Beyond the soap opera that the bid has turned into in Germany (the ultimate test case for cultivation and insurance-backed medical and industry acceptance across the rest of the EU essentially), there are of course, other markets beckoning. This includes all of Eastern Europe and much of the EU. This includes France and the UK immediately.

In other words, no matter what the longer-term impacts will be, this well timed, politically astute Israeli decision is coming at the beginning of what is going to be, as everyone is clearly seeing at the end of January, a momentous and earth-shaking year not only for Europe, but globally.

And that is big business for a little country with an eye on the export game.

Swiss Cloud 9 Begins Importing Cannabis From United States

By Marguerite Arnold
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For all the success of the cannabis market in the United States, there are two big issues that still confound the industry because of a lack of federal reform. The first, of course, is national recognition of an industry that still struggles with banking, insurance and selling products across state lines. The other is international trade.

However, it appears that one Colorado-based company, United Cannabis, has now successfully begun to navigate the complex regulatory and standards puzzle, and further, has set up trade and import agreements in both France and Switzerland. Even more interesting? It managed to do the same before the passage of the Farm Bill.

At present they are exporting to Europe from Florida – but the fact that they are exporting in the European direction at all is a feat still unmatched by many other American firms all looking to do the same thing.

Francis Scanlan, founder of Cloud 9 Switzerland

In Switzerland, they are also partnering with an equally intriguing firm called Cloud 9 Switzerland. We sat down with Francis Scanlan, founder of Cloud 9 Switzerland, to talk about what they are doing and how they are doing it- and from the European perspective.

The First Compliant Swiss Chocolate Maker

Cloud 9 is a start-up that is going head to head with the larger Canadian firms in innovative ways and in several directions. That includes the creation of food and beverage products. It also includes pharmaceuticals.

As of January 22, 2019, Cloud 9 also received approval from Swiss authorities to proceed with production of what will be, as Scanlan describes it, “the first EU-compliant hemp chocolate bar.” The hemp they are using contains a full spectrum hemp extract, which does not fall under the rubric of a so-called “novel food” because hemp has been a product in the consumer market here for a long time.

The product will be on Italian shelves as of the end of Q1 this year. Beyond the regulatory approvals necessary to get to market, it also took him about a year to find and convince a chocolate manufacturer in Switzerland to work with him.

Scanlan describes his year and a half old firm as the “value added” between suppliers, manufacturers and distributors. With a background in the corporate food and beverage industry including a stint at Nestlé, he and his team create the formulations and commercialize new products. And they keep a sharp eye on the regulatory bottom line in Europe.

Cloud 9’s corporate mission, Scanlan says, is to improve the quality of life and wellness of their customers. “We are not in the opportunistic marketing business” he says. “We want to create products that really benefit people. Our motto has always been Win-Win for both our partners and consumers.”

Bringing A Glaucoma Drug To The EU Market

However do not mistake Cloud 9 or even Scanlan himself as a kind of cannabis Willy Wonka one hit wonder. Or a firm that is solely operating in the wellness space. They are also now working to bring a Glaucoma drug into the EU where they will begin with medical trials to start the approval process. That said, Scanlan is confident about the success of this product as well. “It has a great dossier in its home country,” he says. “And that has also already caught the interest of doctors in Italy and Switzerland.”

Beyond that, there are other plans in the works, including the introduction of a transdermal patch that delivers cannabinoids through the skin. “The great thing about this kind of approach,” Scanlan says, “is that it allows people to get over their fear of orally ingested drugs. They don’t like the effect, they can just take it off.” He also noted that the patch uses a patented technology that allows a far more efficient delivery mechanism, which creates a time-delayed medication approach and allows for a 90% transfer of cannabinoids.

In other words, this small, privately funded start-up, using innovative approaches to a market Scanlan knows well, is absolutely in the ring and going to market. And further doing so with a European mindset and operating philosophy that incorporates not only hemp exported from the American hemisphere, but is mixed with a large dollop of good old “American” entrepreneurial gusto and inclinations.

Disclaimer: Cloud9 is a sponsor of the MedPayRx pilot to market program in the EU.

Pesticide Testing: Methods, Strategies & Sampling

By Charles Deibel
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Editor’s Note: The following is based on research and studies performed in their Santa Cruz Lab, with contributions from Mikhail Gadomski, Lab Manager, Ryan Maus, Technical Services Analyst, Dr. Laurie Post, Director of Food Safety & Compliance, Andy Sechler, Lab Director, Toby Astill, Senior Business Development Leader at Perkin Elmer and Charles Deibel, President of Deibel Cannabis Labs.

Pesticides represent the leading cause of batch failures in the cannabis industry. They are also the hardest tests to run in the laboratory, even one equipped with state-of-the-art equipment. The best instruments on the market are HPLC and GC dual mass spectrometer detectors, called “HPLC-qqq”, “GC-qqq,” or just triple quads.

As non-lab people, we envision a laboratory that can take a cannabis sample, inject it into a triple quad and have the machine quickly and effortlessly print out a report of pesticide values. Unfortunately, this is far from reality. The process is much more hands on and complex.In the current chemistry lab, trained analysts have to first program the triple quads to look for the pesticides of concern; in cannabis pesticide testing, this is done by programming the first of two mass spectrometers to identify a single (precursor) mass that is characteristic of the pesticide in question. For BCC requirements in California, this has to be done for all 66 pesticides, one at a time.

Next, these precursor ions are degraded into secondary chemicals called the “product” ions, also called transition ions. The second of the two mass spectrometers is used to analyze these transition ions. This process is graphed and the resulting spectrum is analyzed by trained chemists in the lab, pesticide by pesticide, for all the samples processed that day. If the lab analyzes 10 samples, that translates to 660 spectra to analyze (66 pesticides x 10 samples). When looking at the spectra for each pesticide, the analysts must compare the ratios of the precursor ions to the product ions.

Confirmation Testing

If these spectra indicate a given pesticide may be present, the chemists must then compare the ratios between the precursor and the products. If these ratios are not what is expected, then the analyst must perform confirmation testing to prove the precursor mass either is or is not the pesticide of concern. If the ratios are not what is expected, it means the molecule is similar to the pesticide in question, but may not be that pesticide. This confirmatory testing is key to producing accurate results and not failing batches when dealing with closely related chemicals. This process of analyzing spectra is done in all labs that are performing pesticide testing. In this fledgling industry, there are few published cannabis pesticide methods. 

The need for this type of confirmation testing doesn’t happen all of the time, but when it does, it will take longer than our targeted three-day turn-around time. In the picture above, one precursor mass is ionized into several product masses; but only two are large enough to be used for comparison. In this hypothetical situation, two product masses are produced for every one precursor, the expected ion abundance ratio should be less than 30%. When performing any confirmatory testing, if the ion abundance ratio is >30%, it means the original precursor molecule was not the pesticide of concern. For example, if the ion abundance ratio was 50%, then the original molecule broke down into too many parts; it was not the pesticide we were looking for. This ion abundance ratio threshold was established by FANCO, the international organization that sets guidelines for all pesticide testing.

Testing Strategies

Methodology: In this fledgling industry, there are few published cannabis pesticide methods. The identification of the precursor mass and product ions are not always published, leaving labs to research which ions should be used. This adds to the potential for differences between lab results. Once selected, labs should validate their research, through a series of experiments to ensure the correct precursor and transition (product) ions are being used in the method.

Sample Preparation: Beyond the time-consuming work that is required to develop sound pesticide methods, the extraction step is absolutely critical for credible results. If the pesticides aren’t fully extracted from the cannabis product, then the results will be lower than expected. Sample preparations are often not standardized between labs, so unless a given extraction technique is validated for accuracy, there is the possibility for differences between labs.

Getting a Representative Sample

The current California recommended amount of sample is one gram of product per batch. Batch sizes can vary greatly and it is entirely likely that two different one gram samples can have two different results for pesticides. Has the entire plant been evenly coated with exactly the same amount of pesticide onto every square inch of its leaves? No, probably not. That is why it is imperative to take a “random” sample, by taking several smaller samples from different areas of the entire batch.

Sampling Plans: We can learn a lot from the manufacturing and sampling best practices developed by the food industry through the years. If a food manufacturer is concerned with the possibility of having a bacteria pathogen, like Salmonella, in their finished product, they test the samples coming off their production lines at a statistically relevant level. This practice (theory) is called the sampling plan and it can easily be adapted to the cannabis industry. The basic premise is that the more you test, the higher your likelihood of catching a contaminate. Envision a rectangular swimming pool, but instead of water, it’s filled with jello. In this gelatinous small pool, 100 pennies are suspended at varying levels. The pennies represent the contaminates.

Is the pool homogenized? Is jello evenly represented in the entire pool? Yes. 

Is your concentrate evenly distributed in the extraction vessel? Yes. The question is, where are the pennies in that extraction vessel? The heavy metals, the microbial impurities and the pesticides should be evenly distributed in the extraction vessel but they may not be evenly represented in each sample that is collected. Unfortunately, this is the bane of the manufacturing industry and it’s the unfortunate reality in the food industry. If you take one random cup of jello, will you find the penny? Probably not. But it you take numerous 1 cup samples from random areas within the batch, you increase your chances of finding the contaminate. This is the best approach for sampling any cannabis product.

The best way to approve a batch of cannabis product is to take several random samples and composite them. But you may need to run several samples from this composite to truly understand what is in the batch. In the swimming pool example, if you take one teaspoon scoop, will you find one of the pennies? The best way to find one of the pennies is to take numerous random samples, composite them and increase the number of tests you perform at the lab. This should be done on any new vendor/cultivator you work with, in order to help establish the safety of the product.

Illinois Legislators To Introduce Legalization Bill

By Aaron G. Biros
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It is not news that Illinois Governor J.B. Pritzker favors recreational cannabis legalization. But State Senator Heather Steans (Chicago-D) and State Representative Kelly Cassidy (Chicago-D) introducing a formal bill to legalize recreational cannabis is certainly news. With what they hope will be bipartisan support in the legislature and a Governor on their side, Illinois seems poised to pass legislation legalizing recreational cannabis for adults.

According to the Herald & Register, State Sen. Steans says that public opinion polls show that roughly two-thirds of voters in Illinois favor recreational legalization. “We have a huge opportunity in Illinois to do this right and carefully,” Steans told an audience at a town hall meeting in Springfield, IL yesterday. From what the lawmakers told the public during that town hall meeting, the legislation sounds like it mirrors programs in other states.

Illinois Governor J.B. Pritzker

The bill “would allow Illinoisans 21 and older to purchase and possess up to 30 grams, or about 1 ounce, of marijuana,” Steans and Cassidy said. “Nonresidents would be able to buy and possess half that amount. Use of the drug in public wouldn’t be allowed.” The bill would expunge previous criminal records with respect to cannabis, make it harder for minors to access it and raise an estimated $350 million to $750 million, providing funding for “community development of impoverished neighborhoods,” says Cassidy. “If we don’t address the social-justice issues of this, if we don’t address the collateral consequences of the ‘war on drugs,’ we will have failed,” Cassidy added. The bill would also allow people to grow up to five plants at home, would not allow for public or social consumption, and municipalities, employers and landlords would be able to prohibit possession and use, according to the lawmakers.

In 2015, the state legalized medical cannabis and there are roughly 42,000 patients currently in the medical cannabis program, with roughly 40 qualifying conditions approved for use. Some critics have argued, according to the Chicago Tribune, that before the state legalizes recreational use for adults, they should first expand the list of qualifying conditions for patients. This would provide greater access to those in need while the state implements a regulatory framework for recreational use, which could take upwards of a year to establish the program.

From The Lab

I Was Wrong… und das ist auch gut so!

By Dr. Markus Roggen
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I was wrong. And that’s a good thing! Based on all available data, I assumed that evaporating ethanol from a cannabis oil/ethanol solution would result in terpene loss. As it turns out, it doesn’t. There are so many beliefs and assumptions about cannabis: Cannabis cures cancer!1 Smoking cannabis causes cancer!2 Sativas help you sleep; Indicas make you creative!3,4 CBD is not psychoactive!5 But are these ‘facts’ backed by science? Have they been experimentally tested and validated?

I postulated a theory, designed experiments to validate it and evaluated the results. Simply putting “cannabis backed by science” on your label does not solve the problem. Science is not a marketing term. It’s not even a fixed term. The practice of science is multifaceted and sometimes confusing. It evolved from the traditional model of Inductivism, where observations are used in an iterative process to refine a law/theory that can generalize such observations.6 Closely related is Empiricism, which posits that knowledge can only come from observation. Rationalism, on the other hand, believes that certain truths can be directly grasped by one’s intellect.7 In the last century, the definition of science was changed from the method by which we study something, such as Inductivism or Rationalism, and refocused on the way we explain phenomena. It states that a theory should be considered scientific if, and only if, it is falsifiable.8 All that means is that not the way we study something is what makes it scientific, but the way we explain it.

I wonder how can we use empirical observations and rational deliberations to solve the questions surrounding cannabis? And more importantly, how can we form scientific theories that are falsifiable? Cannabis, the plant, the drug, has long been withheld from society by its legal status. As a result, much of what we know, in fact, the entire industry has thrived in the shadows away from rigorous research. It’s time for this to change. I am particularly concerned by the lack of fundamental research in the field. I am not even talking about large questions, like the potential medical benefit of the plant and its constituents. Those are for later. I’m talking about fundamental, mundane questions like how many lumens per square centimetre does the plant need for optimal THC production? What are the kinetics of cannabis extraction in different solvents? What are the thermodynamics of decarboxylation? Where do major cannabinoids differ or align in terms of water solubility and viscosity?

The lack of knowledge and data in the cannabis field puts us in the precarious position of potentially chasing the wrong goals, not to mention wasting enormous amounts of time and money. Here’s a recent example drawn from personal experience:Certainly, I cannot be the only one who has made an incorrect assumption based on anecdotes and incomplete data?

Some of the most common steps in cannabis oil production involve ethanol solutions. Ethanol is commonly removed from extraction material under reduced pressure and elevated heat in a rotary evaporator. I expected that this process would endanger the terpenes in the oil – a key component of product quality. My theory was that volatile terpenes9 would be lost in the rotary evaporator during ethanol10 removal. The close values of vapor pressure for terpenes and ethanol make this a reasonably assumed possibility.11 In the summer of 2018, I finally got the chance to test it. I designed experiments at different temperatures and pressures, neat and in solution, to quantify the terpene lost in ethanol evaporation. I also considered real life conditions and limitations of cannabis oil manufacturers. After all the experiments were done, the results unequivocally showed that terpenes do not evaporate in a rotary evaporator when ethanol is removed from cannabis extracts.12 As it turns out, I was wrong.

We, as an industry, need to start putting money and effort into fundamental cannabis research programs. But, at least I ran the experiments! I postulated a theory, designed experiments to validate it and evaluated the results. At this point, and only this point, can I conclude anything about my hypothesis, even if that is that my working theory needs to be revised. Certainly, I cannot be the only one who has made an incorrect assumption based on anecdotes and incomplete data?

There is a particular danger when using incomplete data to form conclusions. There are many striking examples in the medical literature and even the casual observer might know them. The case of hormone replacement therapy for menopause and the associated risks of cardiovascular diseases showed how observational studies and well-designed clinical trials can lead to contradicting results.13 In the thirties of the last century, lobotomy became a cure-all technique for mental health issues.14 Dr. Moniz even won the Nobel Prize in Medicine for it.15 And it must come as no surprise when WIRED states “that one generation’s Nobel Prize-winning cure is another generation’s worst nightmare.”16 And with today’s knowledge is impossible to consider mercury as a treatment for syphilis, but that is exactly what it was used as for many centuries.17 All those examples, but the last one in particular should “be a good example of the weight of tradition or habit in the medical practice, […] of the necessity and the difficulties to evaluate the treatments without error.”18 There is the danger that we as cannabis professionals fall into the same trap and believe the old stories and become dogmatic about cannabis’ potential.

We, as an industry, need to start putting money and effort into fundamental cannabis research programs. That might be by sponsoring academic research,19 building in-house research divisions,20 or even building research networks.21 I fully believe in the need for fundamental cannabis research, even the non-sexy aspects.22 Therefore, I set up just that: an independent research laboratory, focused on fundamental cannabis research where we can test our assumptions and validate our theories. Although, I alone cannot do it all. I likely will be wrong somewhere (again). So, please join me in this effort. Let’s make sure cannabis science progresses.

References

  1. No, it does not. There are preliminary in-situ studies that point at anti-cancer effects, but its more complicated. The therapeutic effects of Cannabis and cannabinoids: An update from the National Academies of Sciences, Engineering and Medicine report, Abrams, Donald I., European Journal of Internal Medicine, Volume 49, 7 – 11
  2. No, it does not. National Academies of Sciences, Engineering, and Medicine. 2017. The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research. Washington, DC: The National Academies Press. https://doi.org/10.17226/24625.
  3. No, it does not. The chemical profile of the plant dictates the biological effects on humans, not the shape of the leaf.  Justin T. Fischedick, Cannabis and Cannabinoid Research, Volume: 2 Issue 1: March 1, 2017
  4. Indica and Sativa are outdated terms. Piomelli D, Russo EB. The Cannabis sativa versus Cannabis indica debate: An Interview with Ethan Russo, MD. Cannabis Cannabinoid Res 2016; 1: 44–46.
  5. No, it is. CBD’s supposed “calming effects” is indeed a psychoactive effect. However, it is not intoxicating like THC. Russo E.B., Taming THC: potential cannabis synergy and phytocannabinoid-terpenoid entourage effects.Br. J. Pharmacol. 2011; 163: 1344-1364
  6. As attributed to Francis Bacon.
  7. See the work by philosopher Baruch Spinoza.
  8. As theorized by Karl Popper.
  9. Monoterpenes have a vapor pressure in the low to mid hundreds of Pascals at room temperature.
  10. Vapor pressure of 5.95 kPa at 20˚C.
  11. Furthermore, there is always the possibility of azeotropes in complex mixtures. Azeotropes are mixtures of two or more liquids that have different boiling points individually, but in mixture boil together.
  12. Terpene Retention via Rotary Evaporator Application Note, Heidolph North America
  13. https://www.pharmaceutical-journal.com/research/review-article/establishing-the-risk-related-to-hormone-replacement-therapy-and-cardiovascular-disease-in-women/20202066.article?firstPass=false
  14. https://psychcentral.com/blog/the-surprising-history-of-the-lobotomy/
  15. https://en.wikipedia.org/wiki/António_Egas_Moniz
  16. https://www.wired.com/2011/03/lobotomy-history/
  17. https://www.infezmed.it/media/journal/Vol_21_4_2013_10.pdf
  18. https://www.ncbi.nlm.nih.gov/pubmed/11625051
  19. Canopy Growth funds a professorship of cannabis science at UBC. Tilray collaborates with UCSD on a phase I/II clinical trial.
  20. For examples see: NIBR, PMISCIENCE.
  21. For examples see: CEMI, theAIRnet, Future Sky.
  22. Research that does not lead to short-term stock value spikes but long-term progress

Heavy Metals Testing: Methods, Strategies & Sampling

By Charles Deibel
3 Comments

Editor’s Note: The following is based on research and studies performed in their Santa Cruz Lab, with contributions from Mikhail Gadomski, Lab Manager, Ryan Maus Technical Services Analyst, Laurie Post, Director of Food Safety & Compliance, and Charles Deibel, President Deibel Cannabis Labs.

Heavy metals are common environmental contaminants resulting from human industrial activities such as mining operations, industrial waste, automotive emissions, coal fired power plants and farm/house hold water run-off. They affect the water and soil, and become concentrated in plants, animals, pesticides and the sediments used to make fertilizers. They can also be present in low quality glass or plastic packaging materials that can leach into the final cannabis product upon contact. The inputs used by cultivators that can be contaminated with heavy metals include fertilizers, growing media, air, water and even the clone/plant itself.

The four heavy metals tested in the cannabis industry are lead, arsenic, mercury and cadmium. The California Bureau of Cannabis Control (BCC) mandates heavy metals testing for all three categories of cannabis products (inhalable cannabis, inhalable cannabis products and other cannabis and cannabis products) starting December 31, 2018. On an ongoing basis, we recommend cultivators test for the regulated heavy metals in R&D samples any time there are changes in a growing process including changes to growing media, cannabis strains, a water system or source, packaging materials and fertilizers or pesticides. Cultivators should test the soil, nutrient medium, water and any new clones or plants for heavy metals. Pre-qualifying a new packaging material supplier or a water source prior to use is a proactive approach that could bypass issues with finished product.

Testing Strategies

The best approach to heavy metal detection is the use of an instrument called an Inductively Coupled Plasma Mass Spectrometry (ICP-MS). There are many other instruments that can test for heavy metals, but in order to achieve the very low detection limits imposed by most states including California, the detector must be the ICP-MS. Prior to detection using ICP-MS, cannabis and cannabis related products go through a sample preparation stage consisting of some form of digestion to completely break down the complex matrix and extract the heavy metals for analysis. This two-step process is relatively fast and can be done in a single day, however, the instruments used to perform the digestion are usually the limiting step as the digesters run in a batch of 8-16 samples over a 2-hour period.

Only trace amounts of heavy metals are allowed by California’s BCC in cannabis and cannabis products. A highly sensitive detection system finds these trace amounts and also allows troubleshooting when a product is found to be out of specification.

For example, during the course of testing, we have seen lead levels exceed the BCC’s allowable limit of 0.5 ppm in resin from plastic vape cartridges. An investigation determined that the plastic used to make the vape cartridge was the source of the excessive lead levels. Even if a concentrate passes the limits at the time of sampling, the concern is that over time, the lead leached from the plastic into the resin, increasing the concentration of heavy metals to unsafe levels.

Getting a Representative Sample

The ability to detect trace levels of heavy metals is based on the sample size and how well the sample represents the entire batch. The current California recommended amount of sample is 1 gram of product per batch.  Batch sizes can vary but cannot be larger than 50 pounds of flower. There is no upper limit to the batch sizes for other inhalable cannabis products (Category II).

It is entirely likely that two different 1 gram samples of flower can have two different results for heavy metals because of how small a sample is collected compared to an entire batch. In addition, has the entire plant evenly collected and concentrated the heavy metals into every square inch of it’s leaves? No, probably not. In fact, preliminary research in leafy greens shows that heavy metals are not evenly distributed in a plant. Results from soil testing can also be inconsistent due to clumping or granularity. Heavy metals are not equally distributed within a lot of soil and the one small sample that is taken may not represent the entire batch. That is why it is imperative to take a “random” sample by collecting several smaller samples from different areas of the entire batch, combining them, and taking a 1 g sample from this composite for analysis.

References

California Cannabis CPA. 12/18/2018.  “What to Know About California’s Cannabis Testing Requirements”. https://www.californiacannabiscpa.com/blog/what-to-know-about-californias-cannabis-testing-requirements. Accessed January 10, 2019.

Citterio, S., A. Santagostino, P. Fumagalli, N. Prato, P. Ranalli and S. Sgorbati. 2003.  Heavy metal tolerance and accumulation of Cd, Cr and Ni by Cannabis sativa L.. Plant and Soil 256: 243–252.

Handwerk, B. 2015.  “Modern Marijuana Is Often Laced With Heavy Metals and Fungus.” Smithsonian.com. https://www.smithsonianmag.com/science-nature/modern-marijuana-more-potent-often-laced-heavy-metals-and-fungus-180954696/

Linger, P.  J. Mussig, H. Fischer, J. Kobert. 2002.  Industrial hemp (Cannabis sativa L.) growing on heavy metal contaminated soil: fibre quality and phytoremediation potential. Ind. Crops Prod. 11, 73–84.

McPartland, J. and K. J McKernan. 2017.  “Contaminants of Concern in Cannabis: Microbes, Heavy Metals and Pesticides”.  In: S. Chandra et al. (Eds.) Cannabis sativa L. – Botany and Biotechnology.  Springer International Publishing AG. P. 466-467.  https://www.researchgate.net/publication/318020615_Contaminants_of_Concern_in_Cannabis_Microbes_Heavy_Metals_and_Pesticides.  Accessed January 10, 2019.

Sidhu, G.P.S.  2016.  Heavy metal toxicity in soils: sources, remediation technologies and challenges.   Adv Plants AgricRes. 5(1):445‒446.