Tag Archives: medicine

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
4 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.

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ERP’s Role in Ensuring Traceability & Compliance in the Cannabis Market

By Daniel Erickson
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Recent trends in the cannabis space and media headlines reveal the challenges and complexities of the evolving cannabis industry with regard to traceability and compliance. Keeping abreast of the evolving state of legislative requirements is complex and requires effective procedures to ensure your business will flourish. At the forefront is the need to provide complete seed-to-sale traceability from the cannabis plant to the consumer, increasing the demand for effective tracking and reporting technologies to assure cultivators, manufacturers, processors and dispensaries are able to meet regulatory compliance requirements. An enterprise resource planning (ERP) solution offers a business management solution designed to integrate all aspects from the greenhouse and growing to inventory, recipe/formulation, production, quality and sales, providing complete traceability to meet compliance regulations.

The main force driving cannabusinesses’ adoption of strict traceability and secure systems to monitor the growth, production and distribution of cannabis is the Cole Memorandum of 2013 issued by former US Deputy Attorney General James Cole. The document was designed to prevent the distribution of cannabis to minors, as well as prevent marijuana revenue from being used for criminal enterprises. Due to the non-legal status of cannabis on the federal level, the memo provides guidance for states whose voters have passed legislation permitting recreational or medical cannabis use. If states institute procedures for transparent inventory control and tracking documentation, the memo indicates that the federal government will refrain from interference and/or prosecution. Despite the Trump administration rescinding the memo in early 2018, companies have largely continued to follow its guidelines in an attempt to avoid targeted enforcement of federal law. Local government reporting is a primary reason for strict inventory control, necessitating reliable traceability documentation of the chain-of-custody. 

Process metrics within an ERP solution are essential in providing the accountability necessary to meet required cannabis compliance initiatives. With a centralized, streamlined and secure system, each process becomes documented and repeatable – enabling best practices to provide an audit trail for accountability in all cannabis activities. Whether cultivating, extracting, manufacturing or dispensing cannabis, an ERP’s functionality assists with compliance demands to manage and support traceability and other state-level requirements.

An ERP solution solves the traceability and compliance issues faced by the industry by providing inventory control management and best practices that automates track and trace record keeping from seed to consumer. Growers are also implementing cultivation management solutions within their ERP and highly secure plant identification methods to mobilize greenhouse and inventory to support real-time tracking. Monitoring the loss of inventory due to damage, shrinkage, accidentally or purposeful destruction is efficiently documented to assure that inventory is accounted for. Similar to other process manufacturing industries, it is possible to produce tainted or unsafe products, therefore an ERP solution that supports product recall capabilities is fundamental. With a centralized framework for forward and backward lot, serial and plant ID tracking, the solution streamlines supply chain and inventory transactions to further ensure compliance-driven track and trace record keeping is met.

Local government reporting is a primary reason for strict inventory control, necessitating reliable traceability documentation of the chain-of-custody. Data regarding inventory audit and inspection details, complete with any discrepancies, must be reported to a states’ seed-to-sale tracking system to conform with legal requirements. An ERP utilizes cGMP best practices and reporting as safeguards to keep your company from violating compliance regulations. Failure to complete audits and meet reporting guidelines can be detrimental to your bottom line and lead to criminal penalties or a loss of license from a variety of entities including state regulators, auditors and law enforcement agencies. A comprehensive ERP solution integrates with the state-administered traceability systems more easily and reliably as compared to manual or stand-alone systems – saving time, money and detriment resulting from non-compliance.

Similar to other food and beverage manufacturers, the growing market for cannabis edibles can benefit from employing an ERP system to handle compliance with food safety initiatives – encompassing current and future requirements. Producers of cannabis-infused products for recreational and medicinal use are pursuing Global Food Safety Initiative (GFSI) certification, employing food safety professionals and implementing comprehensive food safety practices–taking advantage of ERP functionality and processes currently in place in similarly FDA regulated industries.

As legalization continues and reporting regulations standardize, dynamic cannabis ERP solutions for growers, processors and dispensaries will evolve to meet the demands and allow for operations to grow profitably.In addition to lot, serial and plant ID tracking, tracing a product back to the strain is equally important. An ERP can efficiently trace a cannabis strain from seedling through the final product, monitoring its genealogy, ongoing clone potency, CBD and THC content ratios and other attributes. The health, weight and required growing conditions of each individual plant or group of plants in the growing stages may be recorded throughout the plant’s lifecycle. In addition, unique plant identification regarding the performance of a particular strain or variety, how it was received by the market and other critical elements are tracked within ERP system. This tracking of particular strains assists with compliance-focused labeling and determining the specific market for selling and distribution of cannabis products.

Collecting, maintaining and accessing traceability and compliance data in a centralized ERP system is significant, but ensuring that information is safe from theft or corruption is imperative as well. An ERP solution with a secure platform that employs automated backups and redundancy plans is essential as it uses best practices to ensure proper procedures are followed within the company. User-based role permissions provide secure accessibility restricted to those with proper authorization. This level of security allows for monitoring and recording of processes and transactions throughout the growing stages, production and distribution; ensuring accountability and proper procedures are being followed. Investing in an ERP solution that implements this level of security aids companies in their data assurance measures and provides proper audit trails to meet regulations.

In this ever-changing industry, regulatory compliance is being met by cannabusinesses through the implementation of an ERP solution designed for the cannabis industry. Industry-specific ERP provides functionality to manage critical business metrics, inventory control, local and state reporting and record keeping, and data security ensuring complete seed-to-sale traceability while offering an integrated business management solution that supports growth and competitive advantage in the marketplace. As legalization continues and reporting regulations standardize, dynamic cannabis ERP solutions for growers, processors and dispensaries will evolve to meet the demands and allow for operations to grow profitably.

French Cannabis Reform Is Finally In The Offing

By Marguerite Arnold
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It is not exactly the storming of the Bastille, but cannabis reform appears to finally be not just in the offing, but crystallizing in the land of the Marseillaise. Why? Apart from the inevitable, particularly now that the European Parliament has put medical reform on a continental agenda?

The first reason is that this is an easy way for the increasingly politically beleaguered French Prime Minister Emmanual Macron to show he is a “man of the people.” In the age of the gilets jaunes or “yellow vests” – protesters on the streets pushing for economic and political justice – a reform of the green kind is just the ticket.

Credit: Dennis Jarvis, Flickr

Secondly, French drug laws are still ridiculously harsh. Use or possession of “narcotics” that are not specifically prescribed by a doctor carries up to a $4,000 fine and a year in prison.

The third reason is that politicians and policy reformers are finally getting the message because of another reason also familiar to American reformers. Locking people up for even minor drug offenses (and French law makes no distinction between cannabis and harder drugs) is a societal menace. It costs the government a lot of money to put people in prison. And the police, just as they are in other places, notably Germany, are tired of engaging in this kind of activity. Particularly when a large number of those they end up arresting are actually patients.

Here is the next issue: The drug laws on the books in France date from December 31, 1970. Similar to the U.S., cannabis of course was treated just like heroin and cocaine. Since that period, French drug arrests have steadily increased (making 67.5% of all arrests as of 2016). Convictions for drug offenses have also increased over ten-fold in the last generation (since the turn of the century).Last year, the CBD market was allowed a little room to flourish in the new grey laws around reform

In a country where approximately 700,000 people use cannabis daily, and 1.4 million use it regularly, this is clearly not sustainable on any front. Particularly where cannabis reform is such a potent weapon in a country where the “yellow vests” have made such a global impression. Cannabis reform, in other words, is an easy fix for a country now thinking about the impact of popular revolutions of other kinds. Not to mention with a history of them. And even more particularly where reform last year allowed “le weed light” (low THC, high CBD strains) to go on sale (with a popular response).

Implications

How fast reform will move here is still obviously uncertain. The current government has been making noise about it for the last two years. Last year, the CBD market was allowed a little room to flourish in the new grey laws around reform (although even here, the first CBD “coffee shops” were shut down last summer almost as soon as they opened).

Given the conservative pace so far, look for France to follow rather than lead. From a CBD perspective, if not a THC one, the country looks very much more like Italy and Germany than Spain or Holland from the cannabis perspective – at least at present.

For such reasons, expect France to follow toute le monde, rather than lead the pack. Decriminalization plus some kind of insurance coverage (similar to Germany) is much more likely to be on the short-term agenda than say a massive rush to embrace the industry (as in Greece). The green revolution may now be in the wings here, but pushed by other unavoidable forces in Europe if not domestically.

That said, to paraphrase the words of the country’s last King, Louis VIX, when France does move on something resembling real reform, it will mean that after that, the “green deluge” will most certainly be on the hoof across the rest of the continent.

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Canopy Growth Announces UK Expansion

By Marguerite Arnold
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On December 28, 2018, Canopy made the unsurprising announcement that it would begin exporting medical cannabis to the UK. The move comes shortly after the formation of Beckley Canopy, the research effort founded in partnership with the Beckley Foundation and Amanda Fielding, the woman who has continued to pioneer the field of cannabinoid research, and the announcement that Canopy will jumpstart medical trials here.

The two events are also connected, as the company will most likely start its export direct to the trials now planned and in general for research purposes as well as pharmacies, based on doctor’s orders.

Impact On The UK Market

Canopy of course, is now in a race with several other Canadian firms to establish market presence both on the trial and patient front. Tilray, Namaste and Wayland Group have all lined up to enter the market, if not having secured first patient orders. That said, entry will be slow for all, namely because of import regulations that may well still go off the cliff because of Brexit.

Intriguingly, however, the Canadians are not the only ones now in the ring. And the “Irish Question” is becoming even more of a potential source of cannabis. That became obvious in the aftermath of an announcement for additional funding and a 25% equity stake in Dublin-based Greenlight Medicines by SOL Global, a Canadian-listed company. Greenlight has already established an extensive network of not only researchers but has a reach at this point to over 1,000 pharmacies across the UK and Ireland.

Bottom line? Look for discussions on access to be fundamentally caught up in the impending, larger political discussions that are still deadlocked, with no certainty in site.And while so far at least, Scotland has remained quiet on the discussion, along with Wales and Cornwall, these are also places domestically in the UK where there could be new cultivation operations coming shortly.

Why? Wales is the “duchy” of none other than the Prince of Wales, Charles, the man who will be the next king of England. For most of his life, he has been pilloried for his ideas about alternative healthcare and organic farming. However, he also owns vast lands in Wales that support him, supported by rents, that are likely, in the near future, to switch to cannabis farming. Whatever reluctance he might have had to take the plunge, this is likely to change course with the next generation when he becomes king. Oversight of the management of all of this bounty will switch to his son, William. And this is a no-brainer, beyond of course, the fact that his sister-in-law, the Duchess of Sussex (Meghan Markle) already has a cannabis brand named after her.

Apart from this political and Royal twist, look for cannabis farming to occur in places like Cornwall, which has temperate weather brought by the Gulf Stream, a tourist economy and a desperate need, like many parts of the UK, for urban renewal. A high tech, high worth agricultural injection, in other words, is just what these parts of the country need.

Scotland, still, is an unanswered question mark, but it is unlikely that much growing will occur in the northern climes. That said, with cannabis production (of all sorts) beginning to wake up, there is no reason that the processing question will escape this part of the British Isles.That also means that calls for domestic cannabis to be grown in the UK itself could become much louder.

What Impact Will Brexit Really Have On Cannabis?

There is no way to really understand this question until the dust settles with negotiations that now have the potential to disrupt all trade between the UK and the rest of the world, including the Republic of Ireland. Ports and transportation through them are facing major disruption. Preparations for an off the cliff exit far beyond cannabis, have also been repeatedly criticized as being far too little, too late.

Bottom line? Look for discussions on access to be fundamentally caught up in the impending, larger political discussions that are still deadlocked, with no certainty in site.

That also means that calls for domestic cannabis to be grown in the UK itself could become much louder. Along with an impetus for greater reform.

Regardless, this drug, so often just below the surface of international affairs for so long, is clearly going to be in the room in larger political discussions now unfolding in the UK.

Impact On National Healthcare

British people, since the end of WWII, have had access to free healthcare thanks to the NHS. That said, after a decade of austerity, the system is now facing crisis unseen since the war. There are 100,000 doctor vacancies at the so-called “Trusts” across the UK which manage regional healthcare. Waiting times even for lifesaving operations are at an all-time high. And approvals for drugs, especially like cannabis, which fall into the territory of “special approval” across Europe are also caught in the mix.

UKflagAs in other countries, in other words, while the news of exports beginning to enter the market is good for patients and the industry beyond that, it is just a start to a longer battle that is still playing out across Europe.

That said, there is another issue in the room that is also absolutely on the table and will be part of the medical cannabis conversation going forward. Digital healthcare–and of all kinds–is being touted as the solution to doctor and service shortages. Look for innovative cannatech solutions in particular that target this market in particular, in the near future.

In the meantime, the green trickle has begun. That said, given all that is at stake and on the table, there are many questions in the room about when the flood will actually take off.

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Israel and Thailand Approve Cannabis Exports

By Marguerite Arnold
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On Christmas Day, not only did Israel, global leader in medical cannabis in particular, finally decide to legalize medical exports, but in a surprise move, so did Thailand.

Both developments are likely to have huge implications on the entire global cannabis discussion, albeit in slightly different ways.The impact will be interesting to watch.

Israel’s Export Decision

The issue of exports from the original home of the medical cannabinoid revolution has been a perennial sticky wicket for the last several years. As the Israeli medical market liberalized at home and certainly in the last five years, the government steadfastly refused to export the drug. Further, the country’s president Benjamin Netanyahu also cut a political deal with Donald Trump to move the Israeli capital from Tel Aviv to Jerusalem that delayed this discussion over the last 18 months. With a global market now exploding that Israel to date has been excluded from and Netanyahu’s political capital tarnished with corruption, things are about to change.

The impact will be interesting to watch. Especially with the network of Israeli production farms also sprinkling around particularly Eastern Europe and Greece.

Thai Surprise

Thailand’s parliament voted to legalize the use of medical cannabis, making it the first country in Southeast Asia to do so.

Here is also what is intriguing: The country is, like Israel, looking at creating a domestic boon with a tightly controlled domestic economy booster. Not to mention clearing the jails, which are filled to bursting with people on even low level drug offenses.

Thailand’s Parliament

And just like Israel, Thailand is also, already, talking protectionist measures to shield domestic producers from being bought out by foreign interests, certainly of the corporate kind.

The Combination Package

In the short term this means, at least on the export front, that there will be more competitors to the Canadian giants now entering the room. And between Israel and Thailand alone, this also means that new strains on the medical side, will begin to enter global medical markets.

For all the future promise of tweaked product, cheap cannabis flower and oil flooding markets globally by importers and distributors realizing that the game is far from over, is going to be the first real challenge the Canadian cannabis companies have yet faced.

In the wake of the news that Epidiolex is not as effective longer term as hoped (which is a common phenomenon in the pharmaceutical industry known as a “drug holiday” where users initially improve and then develop tolerance to the drug), this is also an intriguing new development. This means that new strains are entering the global market at an unprecedented pace, literally competing with pharmaceutical products at a time when reform continues apace.

At a time when cannabis investments (particularly in the US), quadrupled in 2018, this also means that western dollars, if not companies, will begin to find other markets and market outlets.

And that is a Christmas present in 2018 that will reverberate long into the future.

Digipath Labs Now ISO 17025:2017 Accredited

By Aaron G. Biros
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According to a press release published in December, Digipath Labs, based in Las Vegas, Nevada, was recently accredited to the updated ISO standard, ISO 17025:2017. The laboratory received their accreditation from Perry Johnson Laboratory Accreditation (PJLA).

ISO 17025:2005 has long been the standard that labs seek accreditation to, but their newest 2017 edition was recently rolled out and introduced to the market. The new 2017 standard includes some broad changes to terminology, process approach, scope, and it importantly introduces the concept of risk-based thinking.

That concept of risk-based thinking is particularly relevant to the cannabis testing market, where many have argued for more transparency and uniformity in different state regulations and markets. Introducing risk-based thinking in the standard means that assessors also look at the risk of bias, impartiality and assessing measurement uncertainty, which certainly adds a layer of subjectivity to the accreditation.

PJLATracy Szerszen, president/operations manager of PJLA, says the newer standard also includes a provision for a quality management system review among other changes. “We are making sure they are following the standard from a technical standpoint, meaning they have the right equipment, the appropriate personnel and also have a quality management system,” says Szerszen. “November 29, 2020 is the deadline for moving to the new 2017 standard.”

According to Todd Denkin, CEO and founder of Digipath, obtaining the new ISO accreditation poises them for future growth and expansion. “Digipath Labs has now brought its standard of excellence in cannabis testing under the updated ISO-17025:2017 umbrella as we seek to expand our dominance in cannabis testing markets,” says Denkin. “This is a major step in positioning Digipath as a global leader in testing services.”

This Bud’s For You: Tilray Enters The Drinkable Cannabis Market

By Marguerite Arnold
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The race is on for drinkable cannabinoids. In mid-December, Tilray announced a $100 million joint venture with Anheuser Busch to research and develop infused non-alcoholic drinks for the Canadian market.

This is the second big beer company to partner with a cannabis industry leader (see Canopy Growth’s partnership with Constellation Brands), who has just invested another $4 billion in the company.

Molson Coors also announced a deal with Hexo in August. On the non-alcoholic side of the ledger, Coca-Cola and Aurora have also had talks, reportedly eyeing the cannabis market.

Short term in other words, a lot of drinkable cannabis is coming to a market near you.tilray-logo

Why Is Drinkable Cannabis So Intriguing?

Cannabinoids themselves, are not water soluble. However, when cannabinoids are subjected to a process called nano emulsion, (emulsified oil, water and molecules), they can be not only added to drinks but potentially represent one of the most cutting edge forms of drug, vitamin, mineral and overall nutrition delivery. Nanoemulsions are approximately the size of viruses, proteins and antibodies with a transparent or semi-translucent appearance. They also tend to increase bioavailability of substances.

In other words, while the focus on the market as it is developing in Canada is “recreational” and “beverage” use, in fact, this technology can be applied to food. It will also be used, obviously on the medical side of the equation too.

Nanotechnology overall is actually a manufacturing technology that works with atoms to change the structure of matter. When it comes to edibles of all kinds (food, drinks and medications) nutrients are absorbed more uniformly and pass through to membranes directly into human cells.

The impact of that technology, mixed with a revolutionary drug, is no longer theoretical.One of the best known uses of nanotechnology in the world is also one of the most common condiments. Mayonnaise for example, is an emulsion of tiny particles where oil and water are mixed together without separating. That said, these days researchers are developing techniques that allow these tiny droplets to be precisely tailored to give them specific tastes and textures.

The technology, in other words, that the cannabis and major drinks manufacturers are now developing, will allow cannabinoids to be used in food, drinks and medications in ways that go far beyond pills and oils.

This is not your grandparent’s beverage, food, drug or alcohol market in other words. This represents another way for the cannabis industry to lead the way on a range of products far from “canna-beer.” Or even THC-infused social lubricants.

The impact of that technology, mixed with a revolutionary drug, is no longer theoretical.

The Cellular Revolution of Cannabinoids Is Now Here

If allowed to efficiently access cells via nanotechnology, no matter how it is consumed, the idea of a cannabis infused food or drink might well become enough not only to “keep the doctor away” but in general revolutionize concepts of nutrition, not to mention medication.

That said, there are still many questions in general that remain about the safety of this kind of technology within the human body. Nanoceuticals can help bypass typical protective barriers of the body and deliver bio-chemicals that the body would not normally encounter. There has not been a lot of study (yet) on their biodegradability or metabolism of nanotechnologies. Namely the human body may not be able to expel them. They are currently unregulated and can be introduced to the market with little or no evidence of safety or efficacy although this is also on the way. There are concerns that this delivery method could literally disrupt DNA.

Cannabinoids themselves appear to be a systemic biological regulator. But the active ingredients used to emulsify the plant may or may not be.

In an industry in other words, which has systematically been ahead of regulatory approval, starting with legalization itself, the future looks not only highly intriguing, but full of major debates about with what and how human beings are nourished, and treated medically.

As usual, in other words, the cannabis industry, is pioneering a truly brave new world.